Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: yes

Brief summary:
The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to healthy Japanese and non-Japanese participants as multiple doses. In addition, effects of 28-day oral dosing of LY3031207 on the amount of a cholesterol-lowering drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of it will be determined. The effects of LY3031207 after single and 28-day dosing on blood pressure will also be studied. Information about any side effects that may occur will be collected.

Detailed description:

Arms:
arm 1: Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage. arm 2: Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days. arm 3: Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207. arm 4: Daily oral administration of 75 mg LY3031207 or 225 mg LY3031207 for 28 days. Single, oral 10 mg simvastatin open-label dose administered before and after 28-day dosing of LY3031207.

Interventions: intervention 1: Placebo intervention 2: LY3031207 intervention 3: Celecoxib intervention 4: Simvastatin
Intervention descriptions: intervention 1: Capsules administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

Protocol document: