A Study of LY3202626 in Healthy Participants

NCT03023826 | Completed Phase 1 Results

• 2 other identifiers: 15567I7X-MC-LLCE
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

• PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626

  PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

• 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

Study Arms (3)

LY3202626 (R-Fasting)

EXPERIMENTAL

Single oral dose of LY3202626 (R) capsule under fasting conditions.

Drug: LY3202626 (R-Fasting)

LY3202626 (T1-Fasting)

EXPERIMENTAL

Single oral dose of LY3202626 (T1) tablet under fasting conditions.

Drug: LY3202626 (T1-Fasting)

LY3202626 (T1-Fed)

EXPERIMENTAL

Single oral dose of LY3202626 (T1) following a high fat breakfast.

Drug: LY3202626 (T1-Fed)

Interventions

LY3202626 (R-Fasting) DRUG

Administered orally

LY3202626 (R-Fasting)

LY3202626 (T1-Fasting) DRUG

Administered orally

LY3202626 (T1-Fasting)

LY3202626 (T1-Fed) DRUG

Administered orally

LY3202626 (T1-Fed)

Eligibility Criteria

• Age: 21 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
• 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

You may not qualify if:

• 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

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Singapore, 117597, Singapore

Location

MeSH Terms

Interventions

LY3202626

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: January 16, 2017
• First Posted: January 18, 2017
• Study Start: January 15, 2017
• Primary Completion: April 4, 2017
• Study Completion: April 4, 2017
• Last Updated: April 19, 2021
• Results First Posted: April 19, 2021

Record last verified: 2021-03

Locations

SG (1)