A Study of LY2623091 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT02300259
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Itraconazole + LY2623091 (Group 1) LY2623091 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. LY2623091 + Simvastatin (Group 2) Simvastatin LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12. LY2623091 (Group 1) LY2623091 LY2623091 administered orally once on Day 1 of Period 1. LY2623091 (Group 4) LY2623091 LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. LY2623091 + Simvastatin (Group 2) LY2623091 LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12. Diltiazem + LY2623091 (Group 4) LY2623091 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. Tadalafil + LY2623091 (Group 3) LY2623091 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. Simvastatin (Group 2) Simvastatin 20 mg simvastatin administered orally once daily on Day 1. Itraconazole + LY2623091 (Group 1) Itraconazole 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. Tadalafil (Group 3) Tadalafil 5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. Tadalafil + LY2623091 (Group 3) Tadalafil 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. Diltiazem + LY2623091 (Group 4) Diltiazem 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.
- Primary Outcome Measures
Name Time Method 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 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: 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 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: 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Covance Clinical Research Inc
🇺🇸Daytona Beach, Florida, United States