Conditions: Healthy Volunteers
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 48
Healthy volunteers: yes

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:

Arms:
arm 1: LY2623091 administered orally once on Day 1 of Period 1. arm 2: 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. arm 3: 20 mg simvastatin administered orally once daily on Day 1. arm 4: LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12. arm 5: 5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. arm 6: 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. arm 7: LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. arm 8: 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.

Interventions: intervention 1: LY2623091 intervention 2: Itraconazole intervention 3: Simvastatin intervention 4: Tadalafil intervention 5: Diltiazem
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered orally

Protocol document: