NCT04844424

A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Milvexian	Milvexian will be administered orally or via nasogastric route as tablets or capsules.

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-05-06
• Completion: 2022-07-12
• First posted: 2021-04-14
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study