A Study of LY3127760 in Healthy Participants
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01968070
Collaborator
(none)
80
1
5
6
13.4
Study Details
Study Description
Brief Summary
The main purposes of this study are to evaluate the safety and how well the body handles single and multiple doses of increasing strength of study drug, LY3127760. This study includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days prior to enrollment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
80 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of LY3127760 in Healthy Subjects
Study Start Date
:
Oct 1, 2013
Actual Primary Completion Date
:
Apr 1, 2014
Actual Study Completion Date
:
Apr 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3127760 (Single) Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods. |
Drug: LY3127760
Administered orally
Drug: Placebo
Administered orally
|
| Placebo Comparator: Placebo (Single) Single oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance. |
Drug: LY3127760
Administered orally
Drug: Placebo
Administered orally
|
| Experimental: LY3127760 (Multiple) Multiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days. |
Drug: LY3127760
Administered orally
Drug: Placebo
Administered orally
|
| Placebo Comparator: Placebo (Multiple) Multiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance. |
Drug: LY3127760
Administered orally
Drug: Placebo
Administered orally
|
| Active Comparator: Celecoxib (Multiple) Multiple oral doses of 400 mg celecoxib administered QD for 28 days. |
Drug: LY3127760
Administered orally
Drug: Celecoxib
Administered orally
Drug: Placebo
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline to Study Completion (Up To Day 42)]
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Secondary Outcome Measures
- Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760 [Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours]
- PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760 [Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours]
- PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760 [Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours]
- PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760 [Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours]
AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.
- PK: Cmax of Multiple Doses LY3127760 [Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours]
- PK: Tmax of Multiple Doses LY3127760 [Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Overtly healthy males or females as determined by medical history and physical examination
-
Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
-
Female participants not of child-bearing potential
-
Have a body mass index of 18.5 to 32 kilograms per square meter (kg/m^2) inclusive
-
Are normotensive (defined as supine systolic blood pressure [BP] less than 140 millimeters of mercury [mm Hg] and diastolic BP less than 90 mm Hg) without use of any antihypertensives
Exclusion Criteria:
-
Have known allergies to LY3127760, related compounds or any components of the formulation, celecoxib or sulfonamides, or history of significant atopy. Participants with known aspirin allergy or allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded
-
Have any current or prior history of a significant gastrointestinal illness such as peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea
-
Have evidence of other chronic liver disease, including but not limited to chronic alcoholic disease, nonalcoholic steatohepatitis, recent history (within 3 months of screening) of acute viral hepatitis or chronic autoimmune hepatitis
-
Have used any NSAIDs, celecoxib, aspirin or acetaminophen (at doses greater than 1 gram per day), anticoagulants or antiplatelet agents within 14 days of admission
Part 2 and Part 3 only
- Have 1 plus pretrial pitting edema or 2 plus ankle or pedal edema
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. | Evansville | Indiana | United States | 47710 |
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:
NCT01968070
Other Study ID Numbers:
- 15181
- I7A-MC-EACA
First Posted:
Oct 23, 2013
Last Update Posted:
Jun 7, 2019
Last Verified:
Mar 1, 2019
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Part 1 was a single-ascending dose, 2-cohort, 3-period, alternating-group dose-escalation study (cohorts 1-2) and Part 2 of the study was a multiple-ascending dose, 4-cohort, parallel-group, dose-escalation study (cohorts 3-6). Replacement participants received interventions intended for those participants whom discontinued early. |
| Arm/Group Title | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 | Cohort 3 LY3127760 60mg | Cohort 3 Placebo | Cohort 3 Celecoxib 400mg | Cohort 4 LY3127760 200mg | Cohort 4 Placebo | Cohort 4 Celcoxib 400mg | Cohort 5 LY3127760 20mg | Cohort 5 Placebo | Cohort 5 Celecoxib 400mg | Cohort 6 LY3127760 600mg | Cohort 6 Placebo | Cohort 6 Celecoxib 400mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo; | Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760; | Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence. Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760; | Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state; | Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo; | Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence. Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state; | Participants received 60mg LY3127760 capsules orally once daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. | Participants received 200mg LY3127760 capsules orally once daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. | Participants received 20mg LY3127760 capsules orally once daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. | Participants received 300mg LY3127760 capsules orally twice daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. |
| Period Title: Period 1 | ||||||||||||||||||
| STARTED | 4 | 4 | 4 | 4 | 4 | 4 | 10 | 2 | 2 | 9 | 2 | 2 | 9 | 2 | 2 | 9 | 2 | 2 |
| COMPLETED | 4 | 3 | 4 | 2 | 3 | 4 | 8 | 2 | 2 | 9 | 2 | 1 | 9 | 2 | 2 | 8 | 2 | 2 |
| NOT COMPLETED | 0 | 1 | 0 | 2 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Period Title: Period 1 | ||||||||||||||||||
| STARTED | 4 | 4 | 4 | 4 | 3 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 4 | 4 | 4 | 4 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period 1 | ||||||||||||||||||
| STARTED | 4 | 4 | 4 | 4 | 3 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 4 | 4 | 4 | 4 | 3 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 | Cohort 3 LY3127760 60mg | Cohort 3 Placebo | Cohort 3 Celecoxib 400mg | Cohort 4 LY3127760 200mg | Cohort 4 Placebo | Cohort 4 Celcoxib 400mg | Cohort 5 LY3127760 20mg | Cohort 5 Placebo | Cohort 5 Celecoxib 400mg | Cohort 6 LY3127760 300mg | Cohort 6 Placebo | Cohort 6 Celecoxib 400mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo; | Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760; | Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence. Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760; | Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state; | Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence. Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo; | Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence. Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state; | Participants received 60mg LY3127760 capsules orally once daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. | Participants received 200mg LY3127760 capsules orally once daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. | Participants received 20mg LY3127760 capsules orally once daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. | Participants received 300mg LY3127760 capsules orally twice daily. | Participants received placebo capsules orally once daily. | Participants received 400mg Celecoxib capsules orally once daily. | Total of all reporting groups |
| Overall Participants | 4 | 5 | 4 | 6 | 4 | 4 | 10 | 2 | 2 | 9 | 2 | 2 | 9 | 2 | 2 | 9 | 2 | 2 | 80 |
| Age (Count of Participants) | |||||||||||||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
4
100%
|
5
100%
|
4
100%
|
6
100%
|
4
100%
|
4
100%
|
10
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
80
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||||||||||||||||||
| Female |
3
75%
|
2
40%
|
2
50%
|
2
33.3%
|
2
50%
|
0
0%
|
4
40%
|
1
50%
|
0
0%
|
1
11.1%
|
0
0%
|
2
100%
|
0
0%
|
1
50%
|
0
0%
|
1
11.1%
|
1
50%
|
0
0%
|
22
27.5%
|
| Male |
1
25%
|
3
60%
|
2
50%
|
4
66.7%
|
2
50%
|
4
100%
|
6
60%
|
1
50%
|
2
100%
|
8
88.9%
|
2
100%
|
0
0%
|
9
100%
|
1
50%
|
2
100%
|
8
88.9%
|
1
50%
|
2
100%
|
58
72.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||||||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
4
100%
|
5
100%
|
4
100%
|
6
100%
|
4
100%
|
4
100%
|
10
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
80
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
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%
|
1
25%
|
0
0%
|
1
25%
|
1
25%
|
0
0%
|
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
6.3%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
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%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
25%
|
0
0%
|
2
50%
|
0
0%
|
2
50%
|
1
25%
|
3
30%
|
1
50%
|
1
50%
|
2
22.2%
|
1
50%
|
1
50%
|
4
44.4%
|
2
100%
|
1
50%
|
5
55.6%
|
0
0%
|
1
50%
|
28
35%
|
| White |
3
75%
|
5
100%
|
1
25%
|
6
100%
|
1
25%
|
2
50%
|
7
70%
|
1
50%
|
1
50%
|
6
66.7%
|
1
50%
|
1
50%
|
4
44.4%
|
0
0%
|
1
50%
|
4
44.4%
|
2
100%
|
1
50%
|
47
58.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||||||||||||||||
| United States |
4
100%
|
5
100%
|
4
100%
|
6
100%
|
4
100%
|
4
100%
|
10
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
9
100%
|
2
100%
|
2
100%
|
80
100%
|
Outcome Measures
| Title | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
|---|---|
| Description | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. |
| Time Frame | Baseline to Study Completion (Up To Day 42) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug. |
| Arm/Group Title | Part 1: Placebo | Part 1: 20 mg LY3127760 | Part 1: 60 mg LY3127760 | Part 1: 200 mg LY3127760 | Part 1: 600 mg LY3127760 | Part 1: 600 mg LY3127760 (Fasted) | Part 1: 900 mg LY3127760 | Part 2: Placebo | Part 2: 20 mg LY3127760 | Part 2: 60 mg LY3127760 | Part 2: 200 mg LY3127760 | Part 2: 300 mg LY3127760 | Part 2: 400 mg Celecoxib |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo, Single Dose Administered PO | 20 mg LY3127760 Single Dose Administered PO | 60 mg LY3127760 Single Dose Administered PO | 200 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO During Fasted State | 900 mg LY3127760 Single Dose Administered PO | Placebo administered PO, once a day (QD), for 28 days. | 20 mg LY3127760 administered PO, QD, for 28 days. | 60 mg LY3127760 administered PO, QD, for 28 days. | 200 mg LY3127760 administered PO, QD, for 28 days. | 300 mg LY3127760 administered PO, twice daily (BID), for 28 days. | Celecoxib administered PO, QD, for 28 days. |
| Measure Participants | 19 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 9 | 10 | 9 | 9 | 8 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760 |
|---|---|
| Description | |
| Time Frame | Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable AUC data. |
| Arm/Group Title | Part 1: 20 mg LY3127760 | Part 1: 60 mg LY3127760 | Part 1: 200 mg LY3127760 | Part 1: 600 mg LY3127760 | Part 1: 600 mg LY3127760 (Fasted) | Part 1: 900 mg LY3127760 |
|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mg LY3127760 Single Dose Administered PO | 60 mg LY3127760 Single Dose Administered PO | 200 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO During a Fasted State | 900 mg LY3127760 Single Dose Administered PO |
| Measure Participants | 8 | 6 | 6 | 8 | 8 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms•hour/milliliter (ng•hr/mL)] |
NA
(NA)
|
3010
(42)
|
17200
(9)
|
40000
(17)
|
47400
(20)
|
71900
(20)
|
| Title | PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760 |
|---|---|
| Description | |
| Time Frame | Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Cmax data. |
| Arm/Group Title | Part 1: 20 mg LY3127760 | Part 1: 60 mg LY3127760 | Part 1: 200 mg LY3127760 | Part 1: 600 mg LY3127760 | Part 1: 600 mg LY3127760 (Fasted) | Part 1: 900 mg LY3127760 |
|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mg LY3127760 Single Dose Administered PO | 60 mg LY3127760 Single Dose Administered PO | 200 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO During a Fasted State | 900 mg LY3127760 Single Dose Administered PO |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 8 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter (ng/mL)] |
264
(41)
|
890
(19)
|
3880
(33)
|
10300
(37)
|
18900
(40)
|
21600
(27)
|
| Title | PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760 |
|---|---|
| Description | |
| Time Frame | Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Tmax data. |
| Arm/Group Title | Part 1: 20 mg LY3127760 | Part 1: 60 mg LY3127760 | Part 1: 200 mg LY3127760 | Part 1: 600 mg LY3127760 | Part 1: 600 mg LY3127760 (Fasted) | Part 1: 900 mg LY3127760 |
|---|---|---|---|---|---|---|
| Arm/Group Description | 20 mg LY3127760 Single Dose Administered PO | 60 mg LY3127760 Single Dose Administered PO | 200 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO During a Fasted State | 900 mg LY3127760 Single Dose Administered PO |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 8 |
| Median (Full Range) [Hour] |
2.00
|
2.00
|
2.00
|
2.00
|
1.00
|
1.50
|
| Title | PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760 |
|---|---|
| Description | AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort. |
| Time Frame | Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable AUC data. |
| Arm/Group Title | Part 2: 20 mg LY3127760 | Part 2: 60 mg LY3127760 | Part 2: 200 mg LY3127760 | Part 2: 300 mg LY3127760 |
|---|---|---|---|---|
| Arm/Group Description | 20 mg LY3127760 Administered QD PO, Day 1-28 | 60 mg LY3127760 Administered QD PO, Day 1-28 | 200 mg LY3127760 Administered QD PO, Day 1-28 | 300 mg LY3127760 Administered BID PO, Day 1-28 |
| Measure Participants | 9 | 8 | 9 | 8 |
| Geometric Mean (Geometric Coefficient of Variation) [ng•hr/ml] |
1020
(20)
|
4350
(50)
|
11300
(23)
|
19700
(15)
|
| Title | PK: Cmax of Multiple Doses LY3127760 |
|---|---|
| Description | |
| Time Frame | Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Cmax data. |
| Arm/Group Title | Part 2: 20 mg LY3127760 | Part 2: 60 mg LY3127760 | Part 2: 200 mg LY3127760 | Part 2: 300 mg LY3127760 |
|---|---|---|---|---|
| Arm/Group Description | 20 mg LY3127760 Administered QD PO, Day 1-28 | 60 mg LY3127760 Administered QD PO, Day 1-28 | 200 mg LY3127760 Administered QD PO, Day 1-28 | 300 mg LY3127760 Administered BID PO, Day 1-28 |
| Measure Participants | 9 | 8 | 9 | 8 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
301
(19)
|
1210
(53)
|
3650
(27)
|
6170
(22)
|
| Title | PK: Tmax of Multiple Doses LY3127760 |
|---|---|
| Description | |
| Time Frame | Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Tmax data. |
| Arm/Group Title | Part 2: 20 mg LY3127760 | Part 2: 60 mg LY3127760 | Part 2: 200 mg LY3127760 | Part 2: 300 mg LY3127760 |
|---|---|---|---|---|
| Arm/Group Description | 20 mg LY3127760 Administered QD PO, Day 1-28 | 60 mg LY3127760 Administered QD PO, Day 1-28 | 200 mg LY3127760 Administered QD PO, Day 1-28 | 300 mg LY3127760 Administered BID PO, Day 1-28 |
| Measure Participants | 9 | 8 | 9 | 8 |
| Median (Full Range) [hour] |
2.00
|
1.65
|
2.00
|
2.00
|
Adverse Events
| Time Frame | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events. | |||||||||||||||||||||||||
| Arm/Group Title | Placebo (Part 1) | 20 mg LY3127760 (Part 1) | 60 mg LY3127760 (Part 1) | 200 mg LY3127760 (Part 1) | 600 mg LY3127760 (Part 1) | 600 mg LY3127760 (Fasted) (Part 1) | 900 mg LY3127760 (Part 1) | Placebo (Part 2) | 20 mg LY3127760 (Part 2) | 60 mg LY3127760 (Part 2) | 200 mg LY3127760 (Part 2) | 300 mg LY3127760 (Part 2) | 400 mg Celecoxib (Part 2) | |||||||||||||
| Arm/Group Description | Placebo, Single Dose Administered PO | 20 mg LY3127760 Single Dose Administered PO | 60 mg LY3127760 Single Dose Administered PO | 200 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO | 600 mg LY3127760 Single Dose Administered PO During Fasted State | 900 mg LY3127760 Single Dose Administered PO | Placebo, Administered QD PO, Day 1-28 | 20 mg LY3127760 Administered QD PO, Day 1-28 | 60 mg LY3127760 Administered QD PO, Day 1-28 | 200 mg LY3127760 Administered QD PO, Day 1-28 | 300 mg LY3127760 Administered BID PO, Day 1-28 | 400 mg celecoxib Administered QD PO, Day 1-28 | |||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||
| Placebo (Part 1) | 20 mg LY3127760 (Part 1) | 60 mg LY3127760 (Part 1) | 200 mg LY3127760 (Part 1) | 600 mg LY3127760 (Part 1) | 600 mg LY3127760 (Fasted) (Part 1) | 900 mg LY3127760 (Part 1) | Placebo (Part 2) | 20 mg LY3127760 (Part 2) | 60 mg LY3127760 (Part 2) | 200 mg LY3127760 (Part 2) | 300 mg LY3127760 (Part 2) | 400 mg Celecoxib (Part 2) | ||||||||||||||
| 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 | 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) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||
| Placebo (Part 1) | 20 mg LY3127760 (Part 1) | 60 mg LY3127760 (Part 1) | 200 mg LY3127760 (Part 1) | 600 mg LY3127760 (Part 1) | 600 mg LY3127760 (Fasted) (Part 1) | 900 mg LY3127760 (Part 1) | Placebo (Part 2) | 20 mg LY3127760 (Part 2) | 60 mg LY3127760 (Part 2) | 200 mg LY3127760 (Part 2) | 300 mg LY3127760 (Part 2) | 400 mg Celecoxib (Part 2) | ||||||||||||||
| 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/19 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/10 (0%) | 0/9 (0%) | 0/9 (0%) | 0/8 (0%) | |||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||
| Placebo (Part 1) | 20 mg LY3127760 (Part 1) | 60 mg LY3127760 (Part 1) | 200 mg LY3127760 (Part 1) | 600 mg LY3127760 (Part 1) | 600 mg LY3127760 (Fasted) (Part 1) | 900 mg LY3127760 (Part 1) | Placebo (Part 2) | 20 mg LY3127760 (Part 2) | 60 mg LY3127760 (Part 2) | 200 mg LY3127760 (Part 2) | 300 mg LY3127760 (Part 2) | 400 mg Celecoxib (Part 2) | ||||||||||||||
| 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/19 (21.1%) | 2/8 (25%) | 1/8 (12.5%) | 1/8 (12.5%) | 3/8 (37.5%) | 1/8 (12.5%) | 2/8 (25%) | 2/8 (25%) | 4/9 (44.4%) | 5/10 (50%) | 4/9 (44.4%) | 6/9 (66.7%) | 3/8 (37.5%) | |||||||||||||
| Cardiac disorders | ||||||||||||||||||||||||||
| Palpitations | 0/19 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Eye disorders | ||||||||||||||||||||||||||
| Vision blurred | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||||
| Abdominal pain | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 2/9 (22.2%) | 2 | 0/8 (0%) | 0 |
| Abdominal pain lower | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Abdominal pain upper | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 |
| Aphthous stomatitis | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Constipation | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 2/9 (22.2%) | 3 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 |
| Diarrhoea | 1/19 (5.3%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Dyspepsia | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 1/8 (12.5%) | 1 |
| Nausea | 1/19 (5.3%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 2/10 (20%) | 2 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Toothache | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 |
| Vomiting | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 2/10 (20%) | 2 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| General disorders | ||||||||||||||||||||||||||
| Chills | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Fatigue | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Oedema peripheral | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Pain | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||||||
| Gastroenteritis | 1/19 (5.3%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Otitis media | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||
| Excoriation | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Laceration | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||
| Arthralgia | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 1/9 (11.1%) | 2 | 0/8 (0%) | 0 |
| Back pain | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 |
| Flank pain | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||||
| Dizziness | 0/19 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Dysgeusia | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 2/10 (20%) | 2 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Headache | 2/19 (10.5%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/9 (11.1%) | 1 | 2/10 (20%) | 4 | 1/9 (11.1%) | 1 | 1/9 (11.1%) | 1 | 2/8 (25%) | 2 |
| Presyncope | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||||||
| Abnormal dreams | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||
| Dermatitis | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/8 (0%) | 0 |
| Hyperhidrosis | 2/19 (10.5%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Pruritus | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Rash maculo-papular | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/8 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||||||||||
| Flushing | 0/19 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (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 more than 60 days but less than or equal to 180 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 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01968070
Other Study ID Numbers:
- 15181
- I7A-MC-EACA
First Posted:
Oct 23, 2013
Last Update Posted:
Jun 7, 2019
Last Verified:
Mar 1, 2019