Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 1:35 AM
Study NCT ID:
NCT02426632
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Participants
Sponsor:
Janssen Sciences Ireland UC
Organization:
Study Overview
Official Title:
A Phase 1, Double-blind, Randomized, Trial to Evaluate the Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-05
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 primary objective is to evaluate in a double-blinded (neither physician nor participant knows the treatment that the participant receives), fashion the taste of different JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678, 10 milligram/milliliter oral solution without sweetener/flavor).
Detailed Description:
This is a Phase 1, double-blind, randomized (participants taste the same groups of drugs \[formulations\] but in random order), single-center trial in healthy adult participants. The study will include 2 Sessions of 1 day, 1) Session 1, in which participants will receive 6 JNJ-53718678 oral solutions (1 reference and 5 different formulations) sequentially in a randomized order, Scoring of the taste will be done via a questionnaire designed for this purpose; 2) Session 2, within approximately a timeframe of 7 to 14 days after completion of Session 1, participants will taste 2 best scoring tastes coming out of Session 1. The study will consist of a screening phase of approximately 2 weeks, treatment phase of approximately 2 weeks and a post-treatment follow-up phase of 10 days after completion of the last Session. The total study duration for each participant will be approximately 6 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: