The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral tablets compared with milvexian administered as Phase 2 oral capsules (Part 1) and of new concept tablets consisting of a single dose of milvexian administered as oral Tablet 1 and Tablet 2 compared with milvexian administered as Phase 2 oral capsules (Part 3) in healthy participants under fasting and fed conditions; to characterize the pharmacokinetics (PK) of multiple twice daily (BID) doses for 5 days of milvexian administered as DC oral tablets and Phase 2 oral capsules in healthy participants (Part 2) and to assess the effects of dosing time and food timing on the PK of single-dose of milvexian Phase 3 oral tablet formulation in healthy participants (Part 4) and to evaluate the relative bioavailability of a single dose of milvexian administered as oral film-coated DC whole tablets, oral film-coated DC tablets dispersed in water and then mixed with apple sauce, and oral film-coated DC tablets dispersed in water and administered as a suspension using a nasogastric (NG) tube in healthy participants under fasting conditions (Part 5).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
115
Milvexian will be administered orally or via nasogastric route as tablets or capsules.
PRA Health Sciences
Salt Lake City, Utah, United States
Area Under the Plasma Concentration-time Curve of Milvexian from Time Zero to Infinity (AUC [0-Infinity])
AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.
Time frame: Up to 16 months
Part 2: Area under the Plasma Concentration-time Curve of Milvexian From Time Zero to Time of Last Quantifiable Concentration (AUC [0-Last])
AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.
Time frame: Up to 16 months
Maximum Observed Analyte Concentration (Cmax) of Milvexian
Cmax is defined as maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
Parts 1 and 3: AUC (0-Infinity) of Milvexian (Food effect)
AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.
Time frame: Up to 16 months
Parts 1 and 3: AUC (0-Last) of Milvexian (Food effect)
AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.
Time frame: Up to 16 months
Parts 1 and 3: Cmax of Milvexian (Food effect)
Cmax is defined as maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
Actual Sampling Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Milvexian
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
Parts 1 and 3: Tmax of Milvexian (Food effect)
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: Up to 16 months
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