A Study of LY3337641 in Healthy Participants

NCT03099148 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16298I8K-MC-JPDF
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The purposes of this study are to determine:

• If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested.
• How a high-fat meal affects the amount of LY3337641 in the blood/body.
• How safe and well tolerated LY3337641 is. The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU). This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641

  Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641

  Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641

  Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3337641

  Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose

Study Arms (4)

LY3337641 (R-fasted)

EXPERIMENTAL

A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods.

Drug: Reference Formulation (R)

LY3337641 (T1-fasted)

EXPERIMENTAL

A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods.

Drug: LY3337641 (T1)

LY3337641 (T1-fed)

EXPERIMENTAL

A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods.

Drug: LY3337641 (T1)

LY3337641 (T2-fasted)

EXPERIMENTAL

A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods.

Drug: LY3337641 (T2)

Interventions

Reference Formulation (R) DRUG

Administered PO

LY3337641 (R-fasted)

LY3337641 (T1) DRUG

20 mg PO

LY3337641 (T1-fasted); LY3337641 (T1-fed)

LY3337641 (T2) DRUG

20 mg PO

LY3337641 (T2-fasted)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are overtly healthy males or females, as determined by medical history and physical examination
• Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
• Have clinical laboratory test results within normal reference range for the population or investigative site
• Are able and willing to give signed informed consent

You may not qualify if:

• Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
• Have significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
• Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Singapore, 117597, Singapore

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Singapore, Singapore

Location

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 4, 2017
• Study Start: April 4, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 17, 2023
• Results First Posted: October 17, 2023

Record last verified: 2023-10

Locations

SG (2)