Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-01 @ 3:55 AM
Study NCT ID:
NCT07012005
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls
Sponsor:
Shionogi
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of BPN14770 in Participants With Severe Renal Impairment and Healthy Control Participants
Status:
RECRUITING
Status Verified Date:
2025-09
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 purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: