Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 8:00 AM
Study NCT ID:
NCT06181006
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2023-12-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Phase I, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LOXO-305 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 46 days, including screening.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| J2N-OX-JZNS | OTHER | Eli Lilly and Company | View |