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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Placebo
Drug: LY3031207
Drug: Celecoxib
Drug: Simvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.
Drug: Placebo
Capsules administered orally
Experimental: LY3031207
Daily oral administration of 25 milligrams up to 450 milligrams of LY3031207 for 28 days.
Drug: LY3031207
Administered orally
Active Comparator: Celecoxib
Daily oral administration of 400 milligrams celecoxib for 28 days. Positive control for LY3031207.
Drug: Celecoxib
Administered orally
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.
Drug: Simvastatin
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632566

Locations
United States, Hawaii
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01632566     History of Changes
Other Study ID Numbers: 14284, I5W-EW-LBCB
Study First Received: June 25, 2012
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Simvastatin
Celecoxib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014