Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-02 @ 11:11 PM
Study NCT ID:
NCT04033458
Status:
TERMINATED
Last Update Posted:
2025-04-27
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of JNJ-64140284 Solid Dose Formulations in Healthy Male Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Randomized, Open-Label, 5-way Crossover Study in Healthy Male Participants to Evaluate the Bioavailability, Food Effect, Safety and Tolerability of Two Oral Solid Dosage Formulations Relative to an Oral Solution Formulation of JNJ-64140284.
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
stopped because of a business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the pharmacokinetic profile of a single dose of two solid dosage formulations relative to a reference formulation (solution in polyethylene glycol-400 \[PEG-400\]) of JNJ-64140284 in healthy male participants under fasting condition and to assess the effect of food on the bioavailability of two solid dosage formulations of JNJ-64140284.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: