A Study of LY3202626 in Healthy Participants

Healthy Clinical Trial

Official title:

Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023826
• Other study ID #: 15567
• Secondary ID: I7X-MC-LLCE
• Status: Completed
• Phase: Phase 1
• Start date: January 15, 2017
• Est. completion date: April 4, 2017

Study information

• Verified date: March 2021
• 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 way LY3202626 is handled by the body when taken in two different forms

• Whether a high fat meal affects the way the body handles LY3202626

• How well tolerated LY3202626 is

There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

The study will last about 50 days, not including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination

• Female participants must be of non-childbearing potential confirmed by medical history or menopause

• Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria:

• Are investigative site personnel directly affiliated with this study and their immediate families

• Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

• 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• Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product

• Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, 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 a history of head trauma with loss of consciousness within the last 5 years

• Have known or ongoing psychiatric disorders

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3202626 (R-Fasting)
Administered orally
• LY3202626 (T1-Fasting)
Administered orally
• LY3202626 (T1-Fed)
Administered orally

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

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 LY3202626	Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Primary	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of LY3202626	PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-8]) of LY3202626	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Primary	PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626	PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose