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).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Area Under the Plasma Concentration-time Curve of Milvexian from Time Zero to Infinity (AUC [0-Infinity])
Timeframe: 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])
Timeframe: Up to 16 months
Maximum Observed Analyte Concentration (Cmax) of Milvexian
Timeframe: Up to 16 months
Parts 1 and 3: AUC (0-Infinity) of Milvexian (Food effect)
Timeframe: Up to 16 months
Parts 1 and 3: AUC (0-Last) of Milvexian (Food effect)
Timeframe: Up to 16 months
Parts 1 and 3: Cmax of Milvexian (Food effect)
Timeframe: Up to 16 months
Actual Sampling Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Milvexian
Timeframe: Up to 16 months
Parts 1 and 3: Tmax of Milvexian (Food effect)
Timeframe: Up to 16 months