Celerion, Inc.
Lincoln, Nebraska, 68502, United States
NCT Number: NCT06948032
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.
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Notify Me19 year–65 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-specified inclusion and exclusion criteria may apply.
BLU-808 will be administered per schedule specified in the arm description.
BLU-808 matching placebo will be administered per schedule specified in the arm description.
Midazolam will be administered per schedule specified in the arm description.
Time frame: Up to Day 20
Time frame: Up to Day 50
Time frame: Up to Day 6
Time frame: Up to Day 6
Time frame: Up to Day 6
Time frame: Up to Day 6
Time frame: Up to Day 6
Time frame: Up to Day 6
Time frame: Up to Day 6
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 19
Time frame: Up to Day 26
Blueprint Medicines Corporation
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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