A Phase 1 interventional study of LY2409021 and Gemfibrozil in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohorts (groups). Each cohort will participate in two study periods. Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and will also involve screening within 27 days of the start of the study. Part B is only open to participants who successfully completed Part A of the study. Participants in Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day 4. Part B will last for 29 days and will also involve screening within 27 days of the start of the study.
Part B was added to the trial in August 2013, per protocol amendment.
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Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
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Exclusion Criteria:
Part A, Period 1. Participants will receive a single 20-milligram (mg) oral dose of LY2409021 on Day 1.
Drug: LY2409021
Part A, Period 2. Participants will receive a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants will also receive a single 20-mg oral dose of LY2409021 on Day 4.
Drug: LY2409021 · Drug: Gemfibrozil
Part A, Period 1. Participants will receive a single 20-mg oral dose of LY2409021 on Day 1.
Drug: LY2409021
Part A, Period 2. Participants will receive a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
Drug: LY2409021 · Drug: Ketoconazole
Part B. Participants will receive a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
Drug: LY2409021 · Drug: Clarithromycin
Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021
Time frame: Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
Time frame: Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)
| Milestone | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Part B: LY2409021+Clarithromycin |
|---|---|---|---|
| Started | 15 | 15 | 0 |
| Received at least 1 dose of study drug | 15 | 15 | 0 |
| Completed | 15 | 15 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Part B: LY2409021+Clarithromycin |
|---|---|---|---|
| Started | 15 | 15 | 0 |
| Completed part a, entered part b | 6 | 6 | 0 |
| Completed | 15 | 14 | 0 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Milestone | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Part B: LY2409021+Clarithromycin |
|---|---|---|---|
| Started | 0 | 0 | 12 |
| Received at least 1 dose of study drug | 0 | 0 | 12 |
| Completed | 0 | 0 | 12 |
| Not completed | 0 | 0 | 0 |
| nanogram*hours per milliliter (ng*h/mL) | LY2409021 Only (Part A, Cohort 1) | LY2409021+Gemfibrozil (Part A, Cohort 1) | LY2409021 Only (Part A, Cohort 2) | LY2409021+Ketoconazole (Part A, Cohort 2) | LY2409021 Only (Part B Participants, Data From Part A) | LY2409021+Clarithromycin (Part B) |
|---|---|---|---|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | 34700 ± 31 | 35300 ± 35 | 38000 ± 21 | 145000 ± 23 | 37400 ± 25 | 43900 ± 28 |
| nanograms per milliliter (ng/mL) | LY2409021 Only (Part A, Cohort 1) | LY2409021+Gemfibrozil (Part A, Cohort 1) | LY2409021 Only (Part A, Cohort 2) | LY2409021+Ketoconazole (Part A, Cohort 2) | LY2409021 Only (Part B Participants, Data From Part A) | LY2409021+Clarithromycin (Part B) |
|---|---|---|---|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | 431 ± 23 | 410 ± 18 | 445 ± 19 | 471 ± 19 | 419 ± 24 | 467 ± 23 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2409021 Only (Part A, Cohort 1) | — | 0/15 (0%) | 6/15 (40%) |
| Gemfibrozil Only (Part A, Cohort 1) | — | 0/15 (0%) | 1/15 (6.7%) |
| LY2409021+Gemfibrozil (Part A, Cohort 1) | — | 0/15 (0%) | 5/15 (33.3%) |
| LY2409021 Only (Part A, Cohort 2) | — | 0/15 (0%) | 5/15 (33.3%) |
| Ketoconazole Only (Part A, Cohort 2) | — | 0/15 (0%) | 2/15 (13.3%) |
| LY2409021+Ketoconazole (Part A, Cohort 2) | — | 0/15 (0%) | 9/15 (60%) |
| Clarithromycin Only (Part B) | — | 0/12 (0%) | 1/12 (8.3%) |
| LY2409021+Clarithromycin (Part B) | — | 0/12 (0%) | 8/12 (66.7%) |
| Event | LY2409021 Only (Part A, Cohort 1) | Gemfibrozil Only (Part A, Cohort 1) | LY2409021+Gemfibrozil (Part A, Cohort 1) | LY2409021 Only (Part A, Cohort 2) | Ketoconazole Only (Part A, Cohort 2) | LY2409021+Ketoconazole (Part A, Cohort 2) | Clarithromycin Only (Part B) | LY2409021+Clarithromycin (Part B) |
|---|---|---|---|---|---|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 1/15 | 0/15 | 1/15 | 2/15 | 0/15 | 1/15 | 0/12 | 3/12 |
| HeadacheNervous system disorders | 1/15 | 0/15 | 1/15 | 0/15 | 1/15 | 3/15 | 0/12 | 1/12 |
| DiarrhoeaGastrointestinal disorders | 1/15 | 0/15 | 0/15 | 0/15 | 0/15 | 1/15 | 0/12 | 2/12 |
| FatigueGeneral disorders | 0/15 | 0/15 | 2/15 | 0/15 | 0/15 | 0/15 | 0/12 | 0/12 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 0/15 | 2/15 | 0/15 | 0/15 | 0/12 | 0/12 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 0/15 | 0/15 | 0/15 | 2/15 | 0/15 | 1/15 | 0/12 | 0/12 |
| Chapped lipsGastrointestinal disorders | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 1/12 | 0/12 |
| PresyncopeNervous system disorders | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/12 | 1/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/12 | 1/12 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 1/15 | 0/12 | 1/12 |
All participants enrolled in the study.
| Age, Continuous(years) | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Total |
|---|---|---|---|
| Mean | 38.7 ± 10.8 | 39.5 ± 11.6 | 39.1 ± 11.0 |
| Sex: Female, Male(Participants) | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 15 | 15 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 15 | 15 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 6 | 13 |
| White | 8 | 9 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A: LY2409021+Ketoconazole (Cohort 2) | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of May 2013, a primary completion of Nov 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2019, 5 years 4 months after primary completion.
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Gemfibrozil · Ketoconazole · Clarithromycin