A Multiple-dose Study of LY3031207 in Healthy Participants

Overview

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.

Full Title of Study: “A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: Placebo
    • Capsules administered orally
  • Drug: LY3031207
    • Administered orally
  • Drug: Celecoxib
    • Administered orally
  • Drug: Simvastatin
    • Administered orally

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.
  • Experimental: LY3031207
    • Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days.
  • Active Comparator: Celecoxib
    • Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207.
  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
    • Time Frame: Baseline to study completion (treatment completion and follow-up, up to 35 weeks)
    • A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

Secondary Measures

  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
    • Time Frame: Predose up to 48 hours post last dose at Day 28
    • Maximum concentration (Cmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207
    • Time Frame: Predose up to 48 hours post last dose at Day 28
    • Area under the concentration versus time curve in a dosing interval (AUC[0-tau]) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
  • Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207
    • Time Frame: Predose up to 48 hours post last dose at Day 28
    • Time of maximum concentration (Tmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
  • Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin
    • Time Frame: Predose up to 48 hours post dose at Day -3 and Day 28
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin
    • Time Frame: Predose up to 48 hours post dose at Day -3 and Day 28
    • Area under the concentration versus time curve over the range of all measureable concentrations (AUC[0-tlast]) of simvastatin.
  • Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin
    • Time Frame: Predose up to 48 hours post dose at Day -3 and Day 28
  • Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion
    • Time Frame: Baseline, Predose up to 12 hours prior to last dose at Day 28
  • Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion
    • Time Frame: Baseline, Predose up to time of last dose at Day 28
  • Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion
    • Time Frame: Baseline, Predose up to 12 hours prior to last dose at Day 28

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(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, Eli Lilly and Company

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