A Multiple-dose Study of LY3031207 in Healthy Participants

Lilly

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Celecoxib; Drug: Simvastatin; Drug: LY3031207; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01632566

I5W-EW-LBCB (Other Identifier)

14284

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy individuals based on the history and physical examinations as determined by the investigator, including first generation Japanese
• Body mass index between 17.0 and 32.0 kilograms per square meter (kg/m^2), inclusive

Exclusion criteria

• Have known allergies to LY3031207 or any components of the formulation, simvastatin or related compounds (other 3-Hydroxy-3-Methyl-Glutaryl-CoA [HMG CoA] reductase inhibitors), celecoxib, or sulfonamides. Participants with known aspirin allergy or allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.

Treatment:

Drug: Placebo

LY3031207

Experimental group

Description:

Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days.

Treatment:

Drug: LY3031207

Celecoxib

Active Comparator group

Description:

Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207.

Treatment:

Drug: Celecoxib

LY3031207 + Simvastatin

Other group

Description:

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.

Treatment:

Drug: Simvastatin