Study of BLU-808 in Healthy Adult Participants

Phase 1 Completed 95 enrolled Blueprint Medicines Corporation

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start: 2024-08-07
Primary completion: 2025-01-21
Completion: 2025-01-21

Outcome

Met primary endpoint

release “BLU-808 demonstrates wide therapeutic window with rapid, robust and sustained tryptase reductions exceeding 80% in Phase 1 healthy volunteer study” blueprintmedicines.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BLU-808	Unknown	—	Oral
Subject	Midazolam	Small molecule	—	Oral

Indications

No indication recorded.