The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream

NCT01836198 | Completed Phase 1 Results

• 2 other identifiers: 14586I1R-MC-GLBZ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohorts (groups). Each cohort will participate in two study periods. Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and will also involve screening within 27 days of the start of the study. Part B is only open to participants who successfully completed Part A of the study. Participants in Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day 4. Part B will last for 29 days and will also involve screening within 27 days of the start of the study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021

  Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021

  Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)

Study Arms (5)

LY2409021 Only (Part A, Cohort 1)

EXPERIMENTAL

Part A, Period 1. Participants will receive a single 20-milligram (mg) oral dose of LY2409021 on Day 1.

Drug: LY2409021

LY2409021+Gemfibrozil (Part A, Cohort 1)

EXPERIMENTAL

Part A, Period 2. Participants will receive a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants will also receive a single 20-mg oral dose of LY2409021 on Day 4.

Drug: LY2409021; Drug: Gemfibrozil

LY2409021 Only (Part A, Cohort 2)

EXPERIMENTAL

Part A, Period 1. Participants will receive a single 20-mg oral dose of LY2409021 on Day 1.

Drug: LY2409021

LY2409021+Ketoconazole (Part A, Cohort 2)

EXPERIMENTAL

Part A, Period 2. Participants will receive a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.

Drug: LY2409021; Drug: Ketoconazole

LY2409021+Clarithromycin (Part B)

EXPERIMENTAL

Part B. Participants will receive a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.

Drug: LY2409021; Drug: Clarithromycin

Interventions

LY2409021 DRUG

LY2409021 Only (Part A, Cohort 1); LY2409021 Only (Part A, Cohort 2); LY2409021+Clarithromycin (Part B); LY2409021+Gemfibrozil (Part A, Cohort 1); LY2409021+Ketoconazole (Part A, Cohort 2)

Gemfibrozil DRUG

LY2409021+Gemfibrozil (Part A, Cohort 1)

Ketoconazole DRUG

LY2409021+Ketoconazole (Part A, Cohort 2)

Clarithromycin DRUG

LY2409021+Clarithromycin (Part B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are overtly healthy males or females, as determined by medical history and physical examination
• Participants have a body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, at screening
• Participants have a fasting blood glucose of 54 to 110 milligrams per deciliter (mg/dL) (3.0 to 6.1 micromoles per liter \[mmol/L\])

You may not qualify if:

• Participants that have a contraindication to use of clarithromycin
• Participants that have a personal or family history of long QT syndrome
• Participants with a family history of sudden unexplained death or cardiac death in an immediate family member under 60 years of age
• Participants with a personal history of unexplained syncope within the last year
• Participants who have taken drugs or substances known to be an inducer or inhibitor of cytochrome P450 (CYP)3A4 or CYP2C8 or CYP2J2 (for example, St. John's wort, rifampin, ketoconazole, trimethoprim) within 30 days prior to the first dose

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.

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

adomeglivant; Gemfibrozil; Ketoconazole; Clarithromycin

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Results Point of Contact

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

ClinicalTrials.gov@lilly.com

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: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 19, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 8, 2019
• Results First Posted: March 8, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)