A Study of LY2623091 in Healthy Participants
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02300259
Collaborator
(none)
48
1
8
5
9.7
Study Details
Study Description
Brief Summary
The first purpose of this study is to evaluate the effect of itraconazole (and possibly diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get rid of it.
The second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.
The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.
There will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
48 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Study to Determine the Effect of CYP3A Inhibition on the Pharmacokinetics of LY2623091 and the Effect of LY2623091 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects
Study Start Date
:
Nov 1, 2014
Actual Primary Completion Date
:
Apr 1, 2015
Actual Study Completion Date
:
Apr 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY2623091 (Group 1) LY2623091 administered orally once on Day 1 of Period 1. |
Drug: LY2623091
Administered orally
|
| Experimental: Itraconazole + LY2623091 (Group 1) 200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2. |
Drug: LY2623091
Administered orally
Drug: Itraconazole
Administered orally
|
| Experimental: Simvastatin (Group 2) 20 mg simvastatin administered orally once daily on Day 1. |
Drug: Simvastatin
Administered orally
|
| Experimental: LY2623091 + Simvastatin (Group 2) LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12. |
Drug: LY2623091
Administered orally
Drug: Simvastatin
Administered orally
|
| Experimental: Tadalafil (Group 3) 5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. |
Drug: Tadalafil
Administered orally
|
| Experimental: Tadalafil + LY2623091 (Group 3) LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2. |
Drug: LY2623091
Administered orally
Drug: Tadalafil
Administered orally
|
| Experimental: LY2623091 (Group 4) LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. |
Drug: LY2623091
Administered orally
|
| Experimental: Diltiazem + LY2623091 (Group 4) 240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2. |
Drug: LY2623091
Administered orally
Drug: Diltiazem
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091 [Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose]
- Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091 [Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose]
- Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 [Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose]
- Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid [Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose]
- Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid [Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose]
- Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid [Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy participants as determined by medical history, physical examination, clinical laboratory tests, and electrocardiograms (ECGs).
-
Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m^2) inclusive, at screening
-
Female participants must be of non-childbearing potential
Exclusion Criteria:
- 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 | Covance Clinical Research Inc | Daytona Beach | Florida | United States | 32117 |
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:
NCT02300259
Other Study ID Numbers:
- 15523
- I7T-MC-RMAG
First Posted:
Nov 24, 2014
Last Update Posted:
Jun 26, 2020
Last Verified:
Jun 1, 2020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This study planned to enroll 3 groups. After Groups 1 and 2 were enrolled, data from Group 2 were analyzed according to a pre-specified algorithm. Results met criteria to enroll Group 4. (Group 3 was not enrolled.) |
| Arm/Group Title | LY2623091 + Itraconazole (Group 1) | Simvastatin + LY2623091 (Group 2) | LY2623091 + Diltiazem (Group 4) |
|---|---|---|---|
| Arm/Group Description | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 200 mg itraconazole twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6. | Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12. | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. |
| Period Title: Period 1 | |||
| STARTED | 16 | 16 | 16 |
| Received at Least One Dose of Study Drug | 16 | 16 | 16 |
| COMPLETED | 16 | 16 | 14 |
| NOT COMPLETED | 0 | 0 | 2 |
| Period Title: Period 1 | |||
| STARTED | 16 | 0 | 14 |
| COMPLETED | 15 | 0 | 13 |
| NOT COMPLETED | 1 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | LY2623091 + Itraconazole (Group 1) | Simvastatin + LY2623091 (Group 2) | LY2623091 + Diltiazem (Group 4) | Total |
|---|---|---|---|---|
| Arm/Group Description | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6. | Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12. | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. | Total of all reporting groups |
| Overall Participants | 16 | 16 | 16 | 48 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
42.1
(9.4)
|
37.8
(10.1)
|
39.2
(9.3)
|
39.7
(9.5)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
4
25%
|
2
12.5%
|
7
43.8%
|
13
27.1%
|
| Male |
12
75%
|
14
87.5%
|
9
56.3%
|
35
72.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
9
56.3%
|
8
50%
|
8
50%
|
25
52.1%
|
| Not Hispanic or Latino |
7
43.8%
|
8
50%
|
8
50%
|
23
47.9%
|
| Unknown or Not Reported |
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%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
31.3%
|
5
31.3%
|
6
37.5%
|
16
33.3%
|
| White |
10
62.5%
|
9
56.3%
|
10
62.5%
|
29
60.4%
|
| More than one race |
1
6.3%
|
2
12.5%
|
0
0%
|
3
6.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
16
100%
|
16
100%
|
16
100%
|
48
100%
|
Outcome Measures
| Title | Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091 |
|---|---|
| Description | |
| Time Frame | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable Cmax results. |
| Arm/Group Title | LY2623091 (Group 1) | Itraconazole + LY2623091 (Group 1) | LY2623091 (Group 4) | Diltiazem + LY2623091 (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6. | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. . | Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. |
| Measure Participants | 16 | 16 | 16 | 14 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)] |
61.9
(21)
|
66.9
(27)
|
61.8
(34)
|
64.2
(30)
|
| Title | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091 |
|---|---|
| Description | |
| Time Frame | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-infinity) results. |
| Arm/Group Title | LY2623091 (Group 1) | Itraconazole + LY2623091 (Group 1) | LY2623091 (Group 4) | Diltiazem + LY2623091 (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6. | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. |
| Measure Participants | 16 | 16 | 16 | 14 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms*hour/milliliter (ng*h/mL)] |
2540
(27)
|
5660
(31)
|
2390
(39)
|
3360
(43)
|
| Title | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 |
|---|---|
| Description | |
| Time Frame | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-tlast) results. |
| Arm/Group Title | LY2623091 (Group 1) | Itraconazole + LY2623091 (Group 1) | LY2623091 (Group 4) | Diltiazem + LY2623091 (Group 4) |
|---|---|---|---|---|
| Arm/Group Description | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6. | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. |
| Measure Participants | 16 | 15 | 16 | 14 |
| Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL] |
2480
(27)
|
5240
(31)
|
2340
(39)
|
3130
(40)
|
| Title | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid |
|---|---|
| Description | |
| Time Frame | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Group 2 who received at least one dose of study drug and had evaluable Cmax results. |
| Arm/Group Title | Simvastatin (Group 2) | LY2623091 + Simvastatin (Group 2) |
|---|---|---|
| Arm/Group Description | Single oral dose of 20 mg simvastatin on Day 1. | Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12. |
| Measure Participants | 16 | 16 |
| Simvastatin |
7.78
(63)
|
9.89
(45)
|
| Simvastatin Acid |
0.720
(41)
|
0.877
(55)
|
| Title | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid |
|---|---|
| Description | |
| Time Frame | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-infinity) results. |
| Arm/Group Title | Simvastatin (Group 2) | LY2623091 + Simvastatin |
|---|---|---|
| Arm/Group Description | Single oral dose of 20 mg simvastatin on Day 1. | Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12. |
| Measure Participants | 16 | 16 |
| Simvastatin |
17.4
(48)
|
24.1
(34)
|
| Simvastatin Acid |
7.15
(56)
|
8.88
(77)
|
| Title | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid |
|---|---|
| Description | |
| Time Frame | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-tlast) results. |
| Arm/Group Title | Simvastatin (Group 2) | LY2623091 + Simvastatin |
|---|---|---|
| Arm/Group Description | Single oral dose of 20 mg simvastatin on Day 1. | Oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12. |
| Measure Participants | 16 | 16 |
| Simvastatin |
16.5
(49)
|
23.0
(34)
|
| Simvastatin Acid |
5.42
(48)
|
6.87
(87)
|
Adverse Events
| Time Frame | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality. | |||||||||||||||||
| Arm/Group Title | LY2623091 (Group 1) | Itraconazole (Group 1) | Itraconazole + LY2623091 (Group 1) | Simvastatin (Group 2) | LY2623091 (Group 2) | LY2623091 + Simvastatin (Group 2) | LY2623091 (Group 4) | Diltiazem (Group 4) | Diltiazem + LY2623091 (Group 4) | |||||||||
| Arm/Group Description | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | Period 2: Oral doses of 200 mg itraconazole BID on Days 1 through 5. | Period 2: Oral doses of 200 mg itraconazole and 6 mg LY2623091 coadministered once on Day 6. | Single oral dose of 20 mg simvastatin on Day 1. | Oral doses of 24.5 mg LY2623091 QD on Days 3 to 11. | Oral doses of 24.5 mg LY2623091 and 20 mg simvastatin coadministered once on Day 12. | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 through 3. | Period 2: Oral doses of 240 mg diltiazem extended release and 6 mg LY2623091 coadministered once on Day 4. | |||||||||
All Cause Mortality |
||||||||||||||||||
| LY2623091 (Group 1) | Itraconazole (Group 1) | Itraconazole + LY2623091 (Group 1) | Simvastatin (Group 2) | LY2623091 (Group 2) | LY2623091 + Simvastatin (Group 2) | LY2623091 (Group 4) | Diltiazem (Group 4) | Diltiazem + LY2623091 (Group 4) | ||||||||||
| 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 |
||||||||||||||||||
| LY2623091 (Group 1) | Itraconazole (Group 1) | Itraconazole + LY2623091 (Group 1) | Simvastatin (Group 2) | LY2623091 (Group 2) | LY2623091 + Simvastatin (Group 2) | LY2623091 (Group 4) | Diltiazem (Group 4) | Diltiazem + LY2623091 (Group 4) | ||||||||||
| 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 | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/14 (0%) | 0/14 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| LY2623091 (Group 1) | Itraconazole (Group 1) | Itraconazole + LY2623091 (Group 1) | Simvastatin (Group 2) | LY2623091 (Group 2) | LY2623091 + Simvastatin (Group 2) | LY2623091 (Group 4) | Diltiazem (Group 4) | Diltiazem + LY2623091 (Group 4) | ||||||||||
| 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 | 0/16 (0%) | 3/16 (18.8%) | 6/16 (37.5%) | 0/16 (0%) | 4/16 (25%) | 1/16 (6.3%) | 3/16 (18.8%) | 1/14 (7.1%) | 1/14 (7.1%) | |||||||||
| Eye disorders | ||||||||||||||||||
| Lacrimation increased | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 2/16 (12.5%) | 2 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal discomfort | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Abdominal distension | 0/16 (0%) | 0 | 1/16 (6.3%) | 2 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Abdominal pain | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Cheilitis | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Constipation | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 2/16 (12.5%) | 2 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 |
| Diarrhoea | 0/16 (0%) | 0 | 2/16 (12.5%) | 3 | 1/16 (6.3%) | 2 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| General disorders | ||||||||||||||||||
| Cyst | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||
| Hordeolum | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Upper respiratory tract infection | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Viral infection | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Investigations | ||||||||||||||||||
| Aspartate aminotransferase increased | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 1/14 (7.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Neck pain | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||
| Headache | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Sinus headache | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Cough | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Rhinorrhoea | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 2/16 (12.5%) | 2 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Sneezing | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Ecchymosis | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Night sweats | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 2/16 (12.5%) | 2 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (0%) | 0 |
| Rash erythematous | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 1/16 (6.3%) | 1 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/16 (0%) | 0 | 0/14 (0%) | 0 | 0/14 (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:
NCT02300259
Other Study ID Numbers:
- 15523
- I7T-MC-RMAG
First Posted:
Nov 24, 2014
Last Update Posted:
Jun 26, 2020
Last Verified:
Jun 1, 2020