PRA Health Sciences
Salt Lake City, Utah, 84124, United States
NCT Number: NCT04844424
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).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Milvexian will be administered orally or via nasogastric route as tablets or capsules.
Other names: JNJ-70033093, BMS-986177
Time frame: Up to 16 months
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
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
Cmax is defined as maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
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
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
Cmax is defined as maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.
Time frame: Up to 16 months
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.
Janssen Research & Development, LLC
Industry
An Open-Label, Randomized, Crossover Study to Evaluate the Relative Oral Bioavailability, Pharmacokinetics, and Food Effect After Single Dose (for Part 1, Part 3, Part 4 and Part 5) or Multiple-Dose (for Part 2) Administration of JNJ-70033093 (Milvexian) in Healthy Adult Participants Using Tablet, Capsule and Dispersed Tablet Formulations
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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