A Study of LY3337641 in Healthy Participants

Healthy Clinical Trial

Official title:

Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099148
• Other study ID #: 16298
• Secondary ID: I8K-MC-JPDF
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: October 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Reference Formulation (R)
Administered PO
• LY3337641 (T1)
20 mg PO
• LY3337641 (T2)
20 mg PO

Locations

Country	Name	City	State
Singapore	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of LY3337641	Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-8]) 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