Clinical trial NCT01632566: A Multiple-dose Study of LY3031207 in Healthy Participants
Official title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-07-03
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
timeFrame: Baseline to study completion (treatment completion and follow-up, up to 35 weeks)
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
timeFrame: Predose up to 48 hours post last dose at Day 28
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207
timeFrame: Predose up to 48 hours post last dose at Day 28
measure: Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207
timeFrame: Predose up to 48 hours post last dose at Day 28
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin
timeFrame: Predose up to 48 hours post dose at Day -3 and Day 28
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin
timeFrame: Predose up to 48 hours post dose at Day -3 and Day 28
measure: Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin
timeFrame: Predose up to 48 hours post dose at Day -3 and Day 28
measure: Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion
timeFrame: Baseline, Predose up to 12 hours prior to last dose at Day 28
measure: Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion
timeFrame: Baseline, Predose up to time of last dose at Day 28
measure: Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion
timeFrame: Baseline, Predose up to 12 hours prior to last dose at Day 28
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: 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.
state: Hawaii
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: