Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-01 @ 6:21 AM
Study NCT ID:
NCT06948032
Status:
COMPLETED
Last Update Posted:
2025-04-28
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BLU-808 in Healthy Adult Participants
Sponsor:
Blueprint Medicines Corporation
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLU-808 and to Assess the Drug-Drug Interaction With a CYP3A Substrate (Midazolam) and the Effect of Food in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2025-04
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:
This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy adult participants. Part 2 will also include an evaluation of the effect of multiple doses of BLU-808 on the single-dose pharmacokinetics (PK) of midazolam. Part 3 is an open-label, 2-sequence, 2-period, food effect (FE) study in healthy adult participants.
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?: