A Multiple-dose Study of LY3031207 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01632566
• Other study ID #: 14284
• Secondary ID: I5W-EW-LBCB
• Status: Terminated
• Phase: Phase 1
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs	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.	Baseline to study completion (treatment completion and follow-up, up to 35 weeks)
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207	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.	Predose up to 48 hours post last dose at Day 28
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207	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.	Predose up to 48 hours post last dose at Day 28
Secondary	Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207	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.	Predose up to 48 hours post last dose at Day 28
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin		Predose up to 48 hours post dose at Day -3 and Day 28
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin	Area under the concentration versus time curve over the range of all measureable concentrations (AUC[0-tlast]) of simvastatin.	Predose up to 48 hours post dose at Day -3 and Day 28
Secondary	Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin		Predose up to 48 hours post dose at Day -3 and Day 28
Secondary	Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion		Baseline, Predose up to 12 hours prior to last dose at Day 28
Secondary	Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion		Baseline, Predose up to time of last dose at Day 28
Secondary	Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion		Baseline, Predose up to 12 hours prior to last dose at Day 28