A Multiple-dose Study of LY3031207 in Healthy Participants

This study has been terminated.
(Elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in some participants.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01632566
First received: June 25, 2012
Last updated: April 30, 2013
Last verified: April 2013

June 25, 2012
April 30, 2013
June 2012
April 2013   (final data collection date for primary outcome measure)
Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Baseline to study completion (estimated at 16 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01632566 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Maximum concentration (Cmax) of LY3031207 [ Time Frame: Predose up to 48 hours post last dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY3031207 [ Time Frame: Predose up to 48 hours post last dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time of maximum concentration (Tmax) of LY3031207 [ Time Frame: Predose up to 48 hours post last dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum concentration (Cmax) of simvastatin [ Time Frame: Predose up to 48 hours post last dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration curve (AUC) of simvastatin [ Time Frame: Predose up to 48 hours post last dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time of maximum concentration (Tmax) of simvastatin [ Time Frame: Predose up to 48 hours post last dose ] [ Designated as safety issue: No ]
  • Percent change from baseline of urinary prostacyclin I (PGI) metabolite excretion [ Time Frame: Predose up to 12 hours prior to last dose ] [ Designated as safety issue: No ]
  • Percent change from baseline of urinary prostaglandin E (PGE) metabolite excretion [ Time Frame: Predose up to time of last dose ] [ Designated as safety issue: No ]
  • Percent change from baseline of urinary thromboxane A (TXA) metabolite excretion [ Time Frame: Predose up to 12 hours prior to last dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Multiple-dose Study of LY3031207 in Healthy Participants
A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Placebo
    Capsules administered orally
  • Drug: LY3031207
    Administered orally
  • Drug: Celecoxib
    Administered orally
  • Drug: Simvastatin
    Administered orally
  • Placebo Comparator: Placebo
    Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.
    Intervention: Drug: Placebo
  • Experimental: LY3031207
    Daily oral administration of 25 milligrams up to 450 milligrams of LY3031207 for 28 days.
    Intervention: Drug: LY3031207
  • Active Comparator: Celecoxib
    Daily oral administration of 400 milligrams celecoxib for 28 days. Positive control for LY3031207.
    Intervention: Drug: Celecoxib
  • LY3031207 + Simvastatin
    Daily oral administration of 75 milligram or 225 milligram of LY3031207 for 28 days. Single oral 10 milligram dose of simvastatin administered open label before and after 28-day dosing of LY3031207.
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01632566
14284, I5W-EW-LBCB
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP