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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
Celerion, Inc.
Lincoln, Nebraska, United States
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 20
Part 2: Number of Participants With TEAEs
Time frame: Up to Day 50
Part 3: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t)
Time frame: Up to Day 6
Part 3: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 6
Part 1: AUC0-t
Time frame: Up to Day 6
Part 1: Cmax
Time frame: Up to Day 6
Part 1: Terminal Elimination Half-life (t1/2)
Time frame: Up to Day 6
Part 1: Change From Baseline in QTc (Corrected Value of the Interval Between the Q and T Waves on the Electrocardiogram Tracing)
Time frame: Up to Day 6
Parts 1 and 2: Change From Baseline in Serum Tryptase Concentrations
Time frame: Up to Day 6
Part 2: AUC0-t
Time frame: Up to Day 14
Part 2: Cmax
Time frame: Up to Day 14
Part 2: t1/2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to Day 19
Part 3: Number of Participants With TEAEs
Time frame: Up to Day 26