A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants
Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05324124
Collaborator
Eli Lilly and Company (Industry)
46
1
2
2.1
21.9
Study Details
Study Description
Brief Summary
The main purpose of this study is to learn about how food affects selpercatinib in healthy participants. The selpercatinib will be administered in fed and fasted states. Participation could last about 7 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
46 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-Label, Randomized, Two-Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Selpercatinib in Healthy Participants
Actual Study Start Date
:
Apr 19, 2022
Actual Primary Completion Date
:
Jun 22, 2022
Actual Study Completion Date
:
Jun 22, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Selpercatinib (Period 1) Selpercatinib will be administered orally on Day 1 either in fast or fed state. |
Drug: Selpercatinib
Administered orally.
Other Names:
|
| Experimental: Selpercatinib (Period 2) Selpercatinib will be administered orally on Day 8 either in fast or fed state. |
Drug: Selpercatinib
Administered orally.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib [Predose on day 1 until Day 4, and Predose on Day 8 until Day 11]
PK: AUC[0-∞] of Selpercatinib
- PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib [Predose on day 1 until Day 4, and Predose on Day 8 until Day 11]
PK: AUC[0-tlast] of Selpercatinib
- PK: Maximum Concentration (Cmax) of Selpercatinib [Predose on day 1 until Day 4, and Predose on Day 8 until Day 11]
PK: Cmax of Selpercatinib
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and clinical laboratory tests.
Exclusion Criteria:
- Have a history or presence of cardiovascular, respiratory, 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lilly Centre for Clinical Pharmacology | Singapore | Singapore | 138623 |
Sponsors and Collaborators
- Loxo Oncology, Inc.
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Loxo Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT05324124
Other Study ID Numbers:
- 18178
- J2G-MC-JZPA
First Posted:
Apr 12, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Loxo Oncology, Inc.