A Multiple-dose Study of LY3031207 in Healthy Participants

NCT01632566 | Terminated Phase 1 Results

• 2 other identifiers: 14284I5W-EW-LBCB
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207

  Predose up to 48 hours post last dose at Day 28

• Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207

  Predose up to 48 hours post last dose at Day 28

• Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207

  Predose up to 48 hours post last dose at Day 28

• Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin

  Predose up to 48 hours post dose at Day -3 and Day 28

• Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin

  Predose up to 48 hours post dose at Day -3 and Day 28

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.

Drug: Placebo

LY3031207

EXPERIMENTAL

Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days.

Drug: LY3031207

Celecoxib

ACTIVE COMPARATOR

Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207.

Drug: Celecoxib

LY3031207 + Simvastatin

OTHER

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.

Drug: Simvastatin

Interventions

Placebo DRUG

Capsules administered orally

Placebo

LY3031207 DRUG

Administered orally

LY3031207

Celecoxib DRUG

Administered orally

Celecoxib

Simvastatin DRUG

Administered orally

LY3031207 + Simvastatin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Interventions

LY3031207; Celecoxib; Simvastatin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Lilly voluntarily discontinued dosing of LY3031207 for all participants in LBCB because of early discontinuation criteria being met. Data for some endpoints (including blood pressure and Japanese comparison) were incomplete for the planned analyses.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 3, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 27, 2019
• Results First Posted: June 27, 2019

Record last verified: 2019-03

Locations

US (1)