NCT06948032

Study of BLU-808 in Healthy Adult Participants

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Blueprint Medicines Corporation · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BLU-808	BLU-808 will be administered per schedule specified in the arm description.
DRUG	Placebo	BLU-808 matching placebo will be administered per schedule specified in the arm description.
DRUG	Midazolam	Midazolam will be administered per schedule specified in the arm description.

Timeline

• Start date: 2024-08-07
• Primary completion: 2025-01-21
• Completion: 2025-01-21
• First posted: 2025-04-28
• Last updated: 2025-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study