A Phase 1 interventional study of Milvexian in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Other
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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Exclusion Criteria:
Participants will receive a single oral Dose 1 of milvexian as direct compression (DC) tablets under fasting conditions (Treatment A) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as roller compacted (RC) tablets under fasting conditions (Treatment B) in Treatment Period 2 and then a single oral Dose 1 of milvexian Phase 2 oral capsules under fasting conditions (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment C in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment C in Treatment Period 1 followed by Treatment B in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive a single oral Dose 1 of milvexian as DC oral tablets under fed conditions (Treatment D) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as RC oral tablets under fed conditions (Treatment E) in Treatment Period 2 and then a single oral Dose 1 of milvexian as Phase 2 oral capsules under fed conditions (Treatment F) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment E in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment F in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment D in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment E in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment F in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment F in Treatment Period 1, followed by Treatment E in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive twice daily (BID) oral Dose 1 of milvexian DC oral tablets (Treatment G) in Treatment Period 1, followed by BID oral Dose 1 of milvexian Phase 2 oral capsule (Treatment H) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.
Drug: Milvexian
Participants will receive Treatment H in Treatment Period 1, followed by Treatment G in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.
Drug: Milvexian
Participants will receive BID oral Dose 2 of milvexian DC oral tablet (Treatment I) in Treatment Period 1, followed by BID oral Dose 2 of milvexian Phase 2 oral capsule (Treatment J) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.
Drug: Milvexian
Participants will receive Treatment J in Treatment Period 1, followed by Treatment I in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.
Drug: Milvexian
Participants will receive single oral Dose 1 of milvexian as oral Tablet 1 under fasting conditions (Treatment K) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fasting conditions (Treatment L) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 2 oral capsules under fasting conditions (Treatment M) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment L in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 of each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment M in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment K in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment L in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment M in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment M in Treatment Period 1, followed by Treatment L in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive single oral Dose 1 of milvexian oral Tablet 1 under fed conditions (Treatment N) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fed conditions (Treatment O) in Treatment Period 2 and then single oral Dose 1 of milvexian Phase 2 oral capsule under fed conditions (Treatment P) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment O in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment P in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment N in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment O in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment P in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment P in Treatment Period 1, followed by Treatment O in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive single oral Dose 1 of milvexian as Phase 3 oral tablets under fasting conditions (Treatment Q) in Treatment Period 1, followed by single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment R) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment S) in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment R in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment S in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment Q in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment R in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment S in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment S in Treatment Period 1, followed by Treatment R in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive single oral Dose 1 of milvexian as Phase 3 oral tablet under fed conditions (Treatment T) in Treatment Period 1, followed by single oral Dose 2 of milvexian as Phase 3 oral tablet under fed conditions (Treatment U) in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment U in Treatment Period 1, followed by Treatment T in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
All participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive milvexian tablet dispersed in water without a sweetener orally via syringe (Treatment V) in Treatment Period 1, followed by milvexian tablet dispersed in water with sucralose sweetener orally via syringe (Treatment W) in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round.
Drug: Milvexian
All participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive Treatment W in Treatment Period 1, followed by Treatment V in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round.
Drug: Milvexian
Participants will receive a single oral Dose 1 of milvexian as DC whole tablets under fasting conditions (Treatment X) in Treatment Period 1 followed by a single oral Dose 1 of milvexian as DC tablets dispersed in water and then mixed with apple sauce under fasting conditions (Treatment Y) in Treatment Period 2 and then a single oral Dose 1 of milvexian as DC tablets dispersed in water administered through a nasogastric (NG) tube under fasting conditions (Treatment Z) in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment Y in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment Z in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment X in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment Y in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Z in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Participants will receive Treatment Z in Treatment Period 1 followed by Treatment Y in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.
Drug: Milvexian
Milvexian will be administered orally or via nasogastric route as tablets or capsules.
Also known as: JNJ-70033093, BMS-986177
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
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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