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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 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 115 participants.
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).
Interventions
- DRUG Milvexian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04844424
The ClinicalTrials.gov registry entry for NCT04844424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Milvexian is the first listed.
NCT04844424 reports 0 study locations.
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.
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