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A Study of LY2484595 on Pharmacokinetics in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01448824
Collaborator
(none)
82
Enrollment
2
Locations
5
Arms
4
Duration (Months)
41
Patients Per Site
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 2-part study. Part 1 is to determine the safety and tolerability in healthy participants of increasing daily doses of LY2484595 for 14 days to achieve a blood level of LY2484595 much higher than what is needed for therapy. The amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it will be determined. The effect of the study drug on factors in the blood related to cholesterol will be measured.

Part 2 is to determine how ketoconazole affects how much of the study drug, LY2484595, gets into the bloodstream and how long it takes to get rid of it. Information about any side effects that may occur will also be collected.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study is a 2-part, multiple ascending dose (MAD) and drug drug interaction (DDI) study to evaluate the safety and tolerability and the effect of cytochrome P450 (CYP) 3A inhibition by ketoconazole on the pharmacokinetics of LY2484595 in healthy participants.

In the MAD portion (Part 1) of this study, participants in 4 cohorts (Cohorts A through D) will be randomized to receive either LY2484595 (5 ascending dose levels [100 to 1800 mg]) or placebo. Cohorts will have staggered starts ≥7 days from the previous cohort to allow for review of safety and tolerability. The total duration of Part 1 is approximately 13 weeks including screening.

Participants in Cohort A will participate in 2 periods separated by a washout period lasting ≥14 days. During Period 1, participants will receive the starting dose of LY2484595 (100 mg) or placebo once daily (QD) for 14 consecutive days. During Period 2, participants will receive the highest dose of LY2484595 (1800 mg) or placebo QD for 14 consecutive days. Participants will complete a follow-up visit ≥14 days after the last dose of study drug.

Participants in Cohorts B, C, and D will receive LY2484595 (300, 600, and 1200 mg LY2484595, respectively) or placebo QD for 14 consecutive days followed by a follow-up visit ≥14 days after last dose of study drug.

The DDI portion of this study (Part 2) will be open label and consist of 2 periods. The total duration of Part 2 is approximately 10 weeks. LY2484595 (100 mg) will be administered on Day 1 of Period 1 and on Day 5 of Period 2. In Period 2, ketoconazole (400 mg) will be administered QD for 14 consecutive days (13 days alone [Days 1 through 4 and 6 through 14] + 1 day with LY2484595 [Day 5]). There will be a ≥14-day washout period between dosing during Period 1 and Period 2. Participants will return for a follow-up visit ≥14 days after last dose of study drug.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Phase 1 Study to Evaluate the Safety and Tolerability of LY2484595 SDSD-PG Tablets and the Effect of CYP3A Inhibition by Ketoconazole on the Pharmacokinetics of LY2484595 in Healthy Subjects
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1 (Cohort A): 100 mg, 1800 mg LY2484595, Placebo

Period 1: Participants will receive either 100 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14 of Period 1. Washout period lasting ≥14 days. Period 2: Participants will receive either 1800 mg LY2484595 tablets or placebo tablets QD by mouth on Days 1 through 14 of Period 2.

Drug: LY2484595
Administered orally

Drug: Placebo
Administered orally
Experimental: Part 1 (Cohort B): 300 mg LY2484595, Placebo

Participants will receive either 300 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14.

Drug: LY2484595
Administered orally

Drug: Placebo
Administered orally
Experimental: Part 1 (Cohort C): 600 mg LY2484595, Placebo

Participants will receive either 600 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14.

Drug: LY2484595
Administered orally

Drug: Placebo
Administered orally
Experimental: Part 1 (Cohort D): 1200 mg LY2484595, Placebo

Participants will receive either 1200 milligrams (mg) LY2484595 tablets or placebo tablets once daily (QD) by mouth on Days 1 through 14.

Drug: LY2484595
Administered orally

Drug: Placebo
Administered orally
Experimental: Part 2 (Cohort E): 100 mg LY2484595 ± 400 mg Ketoconazole

Period 1: Participants will receive 100 milligrams (mg) LY2484595 tablet by mouth on Day 1 of Period 1. Washout period lasting ≥14 days. Period 2: Participants will receive 400 mg ketoconazole tablets once daily (QD) by mouth on Days 1 through 14 of Period 2. Participants will receive 100 mg LY2484595 tablet by mouth on Day 5 of Period 2.

Drug: LY2484595
Administered orally

Drug: Ketoconazole
Administered orally

Outcome Measures

Primary Outcome Measures

  1. Part 1: Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs [Part 1: Baseline through ≥14 days after last dose of study drug (≥Day 28)]

    The number of participants with 1 or more AEs is summarized cumulatively. In addition, the number of participants with any serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

  2. Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595 [Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose]

    The geometric least squares (LS) means for the maximum observed plasma concentration (Cmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).

  3. Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595 [Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose]

    The median times to maximum observed plasma concentration (Tmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported.

  4. Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595 [Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose]

    The geometric least squares (LS) means of area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).

Secondary Outcome Measures

  1. Pharmacodynamics: Change From Baseline to Day 21 in Cholesteryl Ester Transfer Protein (CETP) Activity [Day 1 (Baseline) and Day 21]

  2. Pharmacodynamics: Change From Baseline to Day 21 in High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG) [Day 1 (Baseline) and Day 21]

  3. Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595 [Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose]

    The maximum observed plasma concentrations (Cmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.

  4. Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595 [Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose]

    The times of maximum observed plasma concentrations (tmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.

  5. Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595 [Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose]

    Exposure to LY2484595 in terms of the area under the concentration-time curves (AUC) after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination

  • Female participants and women not of childbearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause. Postmenopausal is defined as women age >45 with an intact uterus who have not taken hormones or oral contraceptives within the last year, and who have had either cessation of menses greater than or equal to 1 year or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) >40 milli-international units per milliliter (40 international units per liter [IU/L]).

  • Have a body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m^2), inclusive

  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

  • Have venous access sufficient to allow for blood sampling

  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

  • Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site

Exclusion Criteria:

  • Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

  • Have known allergies to LY2484595 or related compounds, contraindications to ketoconazole or related compounds, or allergies to any components of the formulations

  • Are persons who have previously completed or withdrawn from this study or any other study investigating LY2484595 and have previously received the investigational product

  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study and/or poses difficulties in the interpretation of eventual changes occurring during the study

  • Have systolic blood pressure of >140 millimeters of mercury (mmHg) or diastolic blood pressure of >90 mmHg

  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

  • Show evidence of human immunodeficiency virus infection (HIV) and/or positive human HIV antibodies

  • Show evidence of hepatitis C and/or positive hepatitis C antibody

  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen

  • Are women with a positive pregnancy test or women who are lactating

  • Have used or intend to use over-the-counter or prescription medication within 14 days prior to dosing unless deemed acceptable by the investigator and sponsor's medical monitor

  • Use of any drugs or substances that are known to be an inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) (for example, St. John's wort) within 30 days prior to first dose of study drug

  • Have donated blood of more than 500 milliliters (mL) within 30 days prior to first dose of study drug

  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption for the duration of the study (1 unit equals 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)

  • Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any subjects unwilling to adhere to study caffeine restriction

  • Have a daily use of greater than or equal to 5 tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) and are unwilling to refrain from using any tobacco- or nicotine-containing products within 7 days prior to first dose through the follow-up visit

  • Have consumed grapefruit, grapefruit juice, Seville orange, Seville orange juice, or starfruit or products that contain these fruits within 7 days prior to first dose and during the study

  • Unwilling to refrain from daily consumption of black licorice containing glycyrrhizic acid (that is, real licorice)

  • In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Daytona Beach Florida United States 32117
2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dallas Texas United States 75247

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01448824
Other Study ID Numbers:
  • 14460
  • I1V-MC-EIAL
First Posted:
Oct 7, 2011
Last Update Posted:
Apr 2, 2019
Last Verified:
Mar 1, 2019
Keywords provided by Eli Lilly and Company
Low High-density Lipoprotein (HDL)
Cholesterol (HDL-C)
Additional relevant MeSH terms:
Ketoconazole
Evacetrapib

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail This was a 2-part study, multiple ascending dose (MAD) and drug drug interaction (DDI). Participants were randomized to (Part 1) to 4 cohorts (Cohorts A through D) and randomized to receive either LY2484595 (5 ascending dose levels) or placebo. Cohort A consisted of 2 periods separated by a washout period of 14 days. DDI had 2 periods.
Arm/Group Title Part 1 Cohort A Sequence 1 Part 1 Cohort A Sequence 2 Part 1 Cohort A Sequence 3 Part 1 (Cohorts B Through D): Placebo Part 1 Cohort B Part 1 Cohort C Part 1 Cohort D Part 2 Cohort E
Arm/Group Description Period 1: LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1. Washout period lasting ≥14 days. Period 2: LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2. Period 1: Placebo: dose-matched tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1. Washout period lasting ≥ 14 days Period 2: LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2. Period 1: LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 Washout period lasting ≥14 days Period 2: Placebo: tablets, oral administration, QD on Days 1 through 14 of Period 2 Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14. LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14. LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14. LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14. Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1. Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2. LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2.
Period Title: Part 1 Period 1: Multiple Ascending Dose
STARTED 12 4 4 10 16 12 12 0
Received at Least 1 Dose of Study Drug 12 4 4 10 16 12 12 0
COMPLETED 12 4 4 9 14 10 11 0
NOT COMPLETED 0 0 0 1 2 2 1 0
Period Title: Part 1 Period 1: Multiple Ascending Dose
STARTED 12 4 4 0 0 0 0 0
COMPLETED 11 4 4 0 0 0 0 0
NOT COMPLETED 1 0 0 0 0 0 0 0
Period Title: Part 1 Period 1: Multiple Ascending Dose
STARTED 11 4 4 0 0 0 0 0
Received at Least 1 Dose 11 4 4 0 0 0 0 0
COMPLETED 11 4 4 0 0 0 0 0
NOT COMPLETED 0 0 0 0 0 0 0 0
Period Title: Part 1 Period 1: Multiple Ascending Dose
STARTED 0 0 0 0 0 0 0 12
Received at Least 1 Dose of Study Drug 0 0 0 0 0 0 0 12
COMPLETED 0 0 0 0 0 0 0 11
NOT COMPLETED 0 0 0 0 0 0 0 1
Period Title: Part 1 Period 1: Multiple Ascending Dose
STARTED 0 0 0 0 0 0 0 11
COMPLETED 0 0 0 0 0 0 0 11
NOT COMPLETED 0 0 0 0 0 0 0 0
Period Title: Part 1 Period 1: Multiple Ascending Dose
STARTED 0 0 0 0 0 0 0 11
Received at Least 1 Dose of Study Drug 0 0 0 0 0 0 0 11
Completed Dosing on Day 5 0 0 0 0 0 0 0 10
COMPLETED 0 0 0 0 0 0 0 8
NOT COMPLETED 0 0 0 0 0 0 0 3

Baseline Characteristics

Arm/Group Title Part 1 (Cohort A) Sequence 1 Part 1 (Cohort A) Sequence 2 Part 1 (Cohort A) Sequence 3 Part 1 (Cohort B Through D) Placebo Part 1 (Cohort B) Part 1 (Cohort C) Part 1 (Cohort D) Part 2 (Cohort E) Total
Arm/Group Description Participants received 100 milligrams (mg) LY2484595 (tablets, oral administration) QD on Days 1 through 14. Then, received 1800 mg LY2484595 QD on Days 1 through 14 period 2. Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 and 1800 mg LY2484595 on Days 1 through 14 of Period 2). Participants received 100 mg LY2484595 (tablets, oral administration) once daily (QD) on Days 1 through 14. Then, received placebo QD on Days 1 through 14 period 2. Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14. Participants received 300 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14. Participants received 600 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14. Participants received 1200 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14. Participants received 100 mg LY2484595 (tablet, oral administration) as a single dose on Day 1 of Period 1. After a washout period lasting ≥14 days, participants received 400 mg ketoconazole (tablet, oral administration, QD) on Days 1 through 4 of Period 2, 400 mg ketoconazole (tablet, oral administration) and 100 mg LY2484595 (tablet, oral administration) on Day 5 of Period 2, and 400 mg ketoconazole (tablet, oral administration, QD) on Days 6 through 14 of Period 2. Total of all reporting groups
Overall Participants 12 4 4 10 16 12 12 12 82
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
38.4
(11.6)
31.3
(3.9)
41.8
(7.4)
39.4
(13.7)
41.1
(14.3)
39.1
(10.7)
45.8
(11.0)
36.6
(7.9)
39.8
(11.5)
Sex: Female, Male (Count of Participants)
Female
3
25%
1
25%
0
0%
3
30%
5
31.3%
2
16.7%
2
16.7%
3
25%
19
23.2%
Male
9
75%
3
75%
4
100%
7
70%
11
68.8%
10
83.3%
10
83.3%
9
75%
63
76.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
7
58.3%
1
25%
3
75%
4
40%
6
37.5%
8
66.7%
5
41.7%
7
58.3%
41
50%
Not Hispanic or Latino
5
41.7%
3
75%
1
25%
6
60%
10
62.5%
4
33.3%
7
58.3%
5
41.7%
41
50%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2
16.7%
2
2.4%
Asian
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
3
25%
1
25%
1
25%
3
30%
5
31.3%
2
16.7%
1
8.3%
5
41.7%
21
25.6%
White
9
75%
2
50%
3
75%
7
70%
9
56.3%
10
83.3%
8
66.7%
5
41.7%
53
64.6%
More than one race
0
0%
1
25%
0
0%
0
0%
2
12.5%
0
0%
3
25%
0
0%
6
7.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
United States
12
100%
4
100%
4
100%
10
100%
16
100%
12
100%
12
100%
12
100%
82
100%

Outcome Measures

1. Primary Outcome
Title Part 1: Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Description The number of participants with 1 or more AEs is summarized cumulatively. In addition, the number of participants with any serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Time Frame Part 1: Baseline through ≥14 days after last dose of study drug (≥Day 28)

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Part 1 (Cohorts A Through D): Placebo Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Arm/Group Description Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only) LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Measure Participants 18 16 16 12 12 15
AEs
7
58.3%
2
50%
4
100%
2
20%
6
37.5%
11
91.7%
Serious AEs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2. Primary Outcome
Title Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595
Description The geometric least squares (LS) means for the maximum observed plasma concentration (Cmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
Time Frame Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose

Outcome Measure Data

Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
Arm/Group Title Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Arm/Group Description Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2 Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2
Measure Participants 12 10
Least Squares Mean (90% Confidence Interval) [Nanograms per milliliter (ng/mL)]
331.83
643.99
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1 (Cohorts A Through D): Placebo, Part 1, Period 1 (Cohort A): 100 mg LY2484595
Comments
Type of Statistical Test Non-Inferiority or Equivalence
Comments Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of ~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.94
Confidence Interval (2-Sided) 90%
1.39 to 2.72
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
Title Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595
Description The median times to maximum observed plasma concentration (Tmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported.
Time Frame Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose

Outcome Measure Data

Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
Arm/Group Title Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Arm/Group Description Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2. LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2 Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2. LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2
Measure Participants 10 10
Median (Full Range) [Hours (h)]
3.00
3.00
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1 (Cohorts A Through D): Placebo, Part 1, Period 1 (Cohort A): 100 mg LY2484595
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 1.0000
Comments
Method Wilcoxon signed rank
Comments
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.50 to 0.50
Parameter Dispersion Type:
Value:
Estimation Comments
4. Primary Outcome
Title Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595
Description The geometric least squares (LS) means of area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
Time Frame Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose

Outcome Measure Data

Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).
Arm/Group Title Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Arm/Group Description Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2 Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2
Measure Participants 12 9
Geometric Mean (90% Confidence Interval) [Nanograms * hours per milliliter]
5265
12471
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1 (Cohorts A Through D): Placebo, Part 1, Period 1 (Cohort A): 100 mg LY2484595
Comments
Type of Statistical Test Non-Inferiority or Equivalence
Comments Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of ~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio of Geometric LS means
Estimated Value 2.37
Confidence Interval (2-Sided) 90%
1.77 to 3.18
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
Title Pharmacodynamics: Change From Baseline to Day 21 in Cholesteryl Ester Transfer Protein (CETP) Activity
Description
Time Frame Day 1 (Baseline) and Day 21

Outcome Measure Data

Analysis Population Description
Participants who received at least 1 dose of LY2484595 or placebo and had evaluable pharmacodynamic (CETP) data.
Arm/Group Title Part 1 (Cohorts A Through D): Placebo Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Arm/Group Description Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only) LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Measure Participants 18 16 15 11 11 15
Mean (Standard Deviation) [Picomoles per milliliters per minute]
1.3
(6.9)
-0.4
(3.1)
-0.4
(6.3)
-9.1
(8.8)
-9.5
(5.0)
-12.9
(7.5)
6. Secondary Outcome
Title Pharmacodynamics: Change From Baseline to Day 21 in High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
Description
Time Frame Day 1 (Baseline) and Day 21

Outcome Measure Data

Analysis Population Description
Participants who received at least 1 dose of LY2484595 or placebo during Period 1 and had evaluable pharmacodynamic (HDL-C, LDL-C, TG) data.
Arm/Group Title Part 1, Period 1 (Cohorts A Through D): Placebo Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595
Arm/Group Description Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
Measure Participants 14 16 15 11 11
HDL-C
-0.08
(0.17)
0.35
(0.22)
0.49
(0.31)
0.77
(0.49)
0.80
(0.22)
LDL-C
-0.42
(0.74)
-0.16
(0.31)
-0.48
(0.55)
-1.15
(0.93)
-1.01
(0.57)
TG
0.56
(0.87)
0.55
(0.81)
0.44
(0.61)
0.26
(0.38)
0.52
(0.57)
7. Secondary Outcome
Title Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595
Description The maximum observed plasma concentrations (Cmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Time Frame Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose

Outcome Measure Data

Analysis Population Description
Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
Arm/Group Title Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Arm/Group Description LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Measure Participants 16 16 12 12 15
Day 1
628
(79)
1990
(60)
2720
(59)
4450
(53)
3580
(73)
Day 14
978
(41)
1970
(37)
4180
(42)
5410
(48)
5750
(35)
8. Secondary Outcome
Title Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595
Description The times of maximum observed plasma concentrations (tmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Time Frame Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose

Outcome Measure Data

Analysis Population Description
Participants who received at least 1 dose of study drug and had evaluable LY2484595 concentration data.
Arm/Group Title Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Arm/Group Description LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Measure Participants 16 16 12 12 15
Day 1
3.00
3.00
3.00
2.00
2.00
Day 14
4.00
2.00
2.50
2.00
3.00
9. Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595
Description Exposure to LY2484595 in terms of the area under the concentration-time curves (AUC) after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Time Frame Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).
Arm/Group Title Part 1, Period 1 (Cohort A): 100 mg LY2484595 Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 1, Period 2 (Cohort A): 1800 mg LY2484595
Arm/Group Description LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY284595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
Measure Participants 16 16 12 12 15
Day 1
4780
(57)
14500
(47)
21300
(55)
36300
(46)
31300
(63)
Day 14
8110
(30)
17900
(27)
36200
(38)
46900
(43)
56600
(30)

Adverse Events

Time Frame
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Arm/Group Description Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only) LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 LY284595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2 Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2 Period 1: LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1 Washout period lasting ≥ 14 days Period 2: Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2 LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2
All Cause Mortality
Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/18 (0%) 0/16 (0%) 0/15 (0%) 0/16 (0%) 0/12 (0%) 0/12 (0%) 0/12 (0%) 0/11 (0%) 0/10 (0%)
Other (Not Including Serious) Adverse Events
Part 1 (Cohorts A Through D) Part 1, Period 1 (Cohort A) Part 1, Period 2 (Cohort A) Part 1 (Cohort B): 300 mg LY2484595 Part 1 (Cohort C): 600 mg LY2484595 Part 1 (Cohort D): 1200 mg LY2484595 Part 2, Period 1: 100 mg LY2484595 Part 2, Period 2: 400 mg Ketoconazole Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/18 (38.9%) 2/16 (12.5%) 11/15 (73.3%) 4/16 (25%) 2/12 (16.7%) 6/12 (50%) 4/12 (33.3%) 5/11 (45.5%) 2/10 (20%)
Eye disorders
Conjunctivitis 1/18 (5.6%) 1 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Eye irritation 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Eye pruritus 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Lacrimation increased 1/18 (5.6%) 1 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/10 (0%) 0
Gastrointestinal disorders
Abdominal distension 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 2 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Abdominal pain 1/18 (5.6%) 1 0/16 (0%) 0 6/15 (40%) 7 1/16 (6.3%) 1 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Abdominal pain upper 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Constipation 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 1/16 (6.3%) 1 0/12 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/10 (0%) 0
Diarrhoea 0/18 (0%) 0 0/16 (0%) 0 10/15 (66.7%) 13 0/16 (0%) 0 0/12 (0%) 0 2/12 (16.7%) 3 0/12 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0
Dyspepsia 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0
Flatulence 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Gastrooesophageal reflux disease 0/18 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Lip swelling 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/10 (0%) 0
Nausea 1/18 (5.6%) 1 0/16 (0%) 0 6/15 (40%) 9 1/16 (6.3%) 1 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 3/11 (27.3%) 3 0/10 (0%) 0
Oedema mouth 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Oral mucosal erythema 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Paraesthesia oral 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/10 (0%) 0
Vomiting 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 1/16 (6.3%) 1 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0
General disorders
Chills 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Fatigue 0/18 (0%) 0 0/16 (0%) 0 2/15 (13.3%) 2 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Feeling abnormal 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Feeling hot 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Feeling jittery 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Irritability 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0
Pain 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 2/12 (16.7%) 2 0/11 (0%) 0 0/10 (0%) 0
Vessel puncture site pain 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/10 (0%) 0
Infections and infestations
Pharyngitis 1/18 (5.6%) 1 0/16 (0%) 0 2/15 (13.3%) 2 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Rhinitis 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 1/16 (6.3%) 1 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Injury, poisoning and procedural complications
Excoriation 1/18 (5.6%) 1 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Laceration 1/18 (5.6%) 1 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Musculoskeletal and connective tissue disorders
Myalgia 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Nervous system disorders
Dizziness 1/18 (5.6%) 1 0/16 (0%) 0 4/15 (26.7%) 4 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0
Headache 0/18 (0%) 0 0/16 (0%) 0 6/15 (40%) 16 1/16 (6.3%) 1 0/12 (0%) 0 3/12 (25%) 4 0/12 (0%) 0 4/11 (36.4%) 5 0/10 (0%) 0
Muscle contractions involuntary 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 2 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Somnolence 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0
Psychiatric disorders
Agitation 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Respiratory, thoracic and mediastinal disorders
Cough 1/18 (5.6%) 1 0/16 (0%) 0 2/15 (13.3%) 2 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Epistaxis 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Nasal congestion 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Oropharyngeal pain 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Rhinorrhoea 1/18 (5.6%) 1 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Sinus congestion 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Sneezing 0/18 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Skin and subcutaneous tissue disorders
Acne 0/18 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Dry skin 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 1/10 (10%) 1
Erythema 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Hyperhidrosis 1/18 (5.6%) 1 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Pruritus 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 1/12 (8.3%) 1 1/12 (8.3%) 2 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Pruritus generalised 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 1/11 (9.1%) 1 0/10 (0%) 0
Rash 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 1/10 (10%) 1
Rash generalised 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Urticaria 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/10 (0%) 0
Vascular disorders
Capillary fragility 0/18 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 1/16 (6.3%) 1 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0
Flushing 0/18 (0%) 0 0/16 (0%) 0 2/15 (13.3%) 2 0/16 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/10 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Chief Medical Officer
Organization Eli Lilly and Company
Phone 800-545-5979
Email
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01448824
Other Study ID Numbers:
  • 14460
  • I1V-MC-EIAL
First Posted:
Oct 7, 2011
Last Update Posted:
Apr 2, 2019
Last Verified:
Mar 1, 2019