A Multiple-dose Study of LY3031207 in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules administered orally

LY3031207

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

Group Type EXPERIMENTAL

LY3031207

Intervention Type DRUG

Administered orally

Celecoxib

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

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Administered orally

LY3031207 + Simvastatin

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.

Group Type OTHER

Simvastatin

Intervention Type DRUG

Administered orally

Interventions

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Placebo

Capsules administered orally

Intervention Type DRUG

LY3031207

Administered orally

Intervention Type DRUG

Celecoxib

Administered orally

Intervention Type DRUG

Simvastatin

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes