A Study of LY3202626 in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT03023826|
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : April 19, 2021
Last Update Posted : April 19, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: LY3202626 (R-Fasting) Drug: LY3202626 (T1-Fasting) Drug: LY3202626 (T1-Fed)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626|
|Study Start Date :||January 15, 2017|
|Actual Primary Completion Date :||April 4, 2017|
|Actual Study Completion Date :||April 4, 2017|
Experimental: LY3202626 (R-Fasting)
Single oral dose of LY3202626 (R) capsule under fasting conditions.
Drug: LY3202626 (R-Fasting)
Experimental: LY3202626 (T1-Fasting)
Single oral dose of LY3202626 (T1) tablet under fasting conditions.
Drug: LY3202626 (T1-Fasting)
Experimental: LY3202626 (T1-Fed)
Single oral dose of LY3202626 (T1) following a high fat breakfast.
Drug: LY3202626 (T1-Fed)
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose ]Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
- PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose ]PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626
- PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023826
|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, 117597|
|Study Director:||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|