Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-31 @ 1:16 PM
Study NCT ID:
NCT01662661
Status:
COMPLETED
Last Update Posted:
2013-07-24
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants
Sponsor:
Janssen R&D Ireland
Organization:
Study Overview
Official Title:
A Phase I, Open-Label, Randomized, 2-way Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of a Single Oral Dose of JNJ-47910382 Formulated as a Tablet and as a Suspension
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 assess the relative bioavailability (the degree to which the study medication becomes available in the blood circulation) of JNJ-47910382, given as an uncoated tablet and as a suspension, after a single oral dose of 200 mg in healthy adult participants under fed conditions.
Detailed Description:
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 2-way crossover study (method used to switch participants from one treatment arm to another in a clinical study) to compare the oral bioavailability of JNJ-47910382 formulated as an uncoated tablet and as a suspension, in healthy participants. The study consists of 3 phases, including, a screening phase, an open-label treatment phase, and a follow up phase. The screening phase will be within 21 days before administration of the first dose of study medication. After screening, participants will be randomized according to a classical 2 sequence (ie, treatment sequence AB \[where the participants will first receive treatment A and then treatment B\] and sequence BA \[where the participants will first receive treatment B and then treatment A\]), 2-period crossover design to receive the study medication in the treatment phase. In each session (Session 1 or Session 2), participants will receive either Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension, or Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet. There will be a washout period (period when participant is not receiving any study medication) of at least 7 to 14 days between the 2 sessions. The follow up phase will include 2 follow up visits after intake of study medication in last treatment session. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, and specific toxicities will be monitored throughout the study. The duration of the study will be at least 11 to 18 days (screening and follow up phase not included).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: