A Multiple-dose Study of LY3031207 in Healthy Participants

Condition(s) targeted: Healthy Volunteers

Intervention: Placebo (Drug); LY3031207 (Drug); Celecoxib (Drug); Simvastatin (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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 LY3131207 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 LY3131207 after single and 28-day dosing on blood pressure will also be studied. Information about any side effects that may occur will be collected.

Official title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Number of participants with one or more drug related adverse events (AEs) or any serious AEs

Secondary outcome:

Pharmacokinetics: Maximum concentration (Cmax) of LY3031207

Pharmacokinetics: Area under the concentration curve (AUC) of LY3031207

Pharmacokinetics: Time of maximum concentration (Tmax) of LY3031207

Pharmacokinetics: Maximum concentration (Cmax) of simvastatin

Pharmacokinetics: Area under the concentration curve (AUC) of simvastatin

Pharmacokinetics: Time of maximum concentration (Tmax) of simvastatin

Percent change from baseline of urinary prostacyclin I (PGI) metabolite excretion

Percent change from baseline of urinary prostaglandin E (PGE) metabolite excretion

Percent change from baseline of urinary thromboxane A (TXA) metabolite excretion

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Honolulu, Hawaii, United States

Starting date: June 2012
Last updated: April 30, 2013