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NCT04844424 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
NCT04844424: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT04844424 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 115 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04844424, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
Study 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).
Primary Outcome
AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.
Interventions
- DRUG Milvexian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 1 |
What the finished NCT04844424 record still lists
NCT04844424 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher).
The record links to 0 conditions, and to 1 intervention - of which Milvexian is the first listed.
NCT04844424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04844424 about?
NCT04844424 is a clinical study titled "A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants". 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 ta...
What is the current status of trial NCT04844424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2021-04-14. Estimated completion is 2022-07-12.
What interventions are being tested in trial NCT04844424?
The interventions under investigation include: Milvexian (DRUG).
Who is sponsoring clinical trial NCT04844424?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04844424's enrollment target sits among peer trials
115 504th of 2000 higher than 1,494 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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