Part 1 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following oral administration of 3 prototype formulations in healthy participants compared to an immediate release capsule formulation (reference), and also to determine the relative bioavailability of a selected BOS172767 prototype formulation in the fed and fasted states. Part 2 of the study will be conducted to provide additional information on the safety and tolerability of escalating single doses of the selected formulation of BOS172767 in healthy participants, to evaluate the PK profile following increased single doses of the selected formulation of BOS172767 following administration in healthy participants, and also to evaluate the dose linearity of the selected prototype. Part 3 of the study will be conducted to provide additional information on the safety, tolerability, and PK of the selected formulation of BOS172767 following multiple ascending doses (MADs) over 14 days of dosing in healthy participants.
Part 1 is comprised of a single-dose, part-randomized, open-label, 6-way crossover in 12 healthy participants. Participants will be dosed on 6 separate occasions (in 6 treatment periods), and will receive a single prototype of BOS172767 in each treatment period. Part 2 is comprised of a single ascending dose, fixed-sequence, open-label, 3-way crossover with an optional fourth dosing period in 10 healthy participants. Participants will be dosed on 4 separate occasions (in 4 treatment periods), and will receive a single prototype of BOS172767 in each treatment period. Part 3 is a double-blind (sponsor-open), placebo-controlled, randomized MAD part in 36 healthy participants (12 per study cohort). Participants will be dosed on 3 separate occasions (in 3 treatment periods), and will receive a single prototype of BOS172767 in each treatment period. Parts 2 and 3 are contingent upon successful completion of Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
28
Oral tablets
Oral capsules
Oral capsules
Oral capsules
Oral capsules
Oral tablets
Oral tablets
Quotient Sciences
Nottingham, United Kingdom
Parts 1, 2, and 3: Number of participants with any treatment-emergent serious adverse event (TESAE)
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with any treatment-emergent non-serious adverse event (TEAE)
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant physical examination findings
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant safety laboratory test findings
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant vital sign values
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant electrocardiogram findings
Time frame: up to 33 weeks
Parts 1 and 2: Plasma concentration of BOS172722
Time frame: predose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 hours postdose (Day 1); 24 and 36 hours postdose (Day 2); 48 hours postdose (Day 3)
Part 2 (Regimen I): Plasma concentration of BOS172722
Time frame: admission to pre-dose (admission to dosing), 0 to 6 (Day 1), 6 to 12 (Day 1), 12 to 24 (Day 1), and 24 to 48 (Days 2 to 3) hours postdose
Part 3: Plasma concentration of BOS172722
Time frame: Days 1 and 7: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose. Days 4, 6, 9, 11, and 12: pre-dose. Day 14: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-final dose
Part 3 (Regimen M): Plasma concentration of BOS172722
Time frame: admission to pre-dose on Day 1; 0 to 6, 6 to 12, and 12 to 24 hours postdose on Days 1, 7, and 14
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