- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01662661
A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants
July 22, 2013 updated by: Janssen R&D Ireland
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antwerp, Belgium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be healthy on the basis of physical examination, medical history, vital signs and the results of blood biochemistry, hematology and coagulation tests and a urinalysis performed (at screening)
- Must have a triplicate 12-lead electrocardiogram consistent with normal cardiac conduction and function
- Must be a non-smoker for at least 3 months prior to selection
- If a female, must be postmenopausal or surgically sterile
- Female participants must have a negative serum pregnancy test (at screening)
Exclusion Criteria:
- Had a past history of heart arrhythmias, history of risk factors for Torsade de Pointes syndrome (an uncommon and distinctive form of polymorphic ventricular tachycardia characterized by a gradual change in the amplitude and twisting of the QRS complexes around the isoelectric line on the electrocardiogram) or having low potassium levels in the blood
- History or suspicion of alcohol, barbiturate, amphetamine, recreational or narcotic drug use that could impact compliance to protocol requirements and/or safety
- Hepatitis A, B or C infection (at screening)
- A positive human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2) test (at screening)
- Have a positive urine drug test or alcohol breath test (at screening)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm AB
Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension followed by Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet, administered on Day 1.
|
Type=exact number, unit=mg, number=200, form=suspension, route=oral.
JNJ-47910382 administered on Day 1.
Type=exact number, unit=mg, number=200, form=tablet, route=oral.
JNJ-47910382 administered on Day 1.
|
Experimental: Arm BA
Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet followed by Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension, administered on Day 1.
|
Type=exact number, unit=mg, number=200, form=suspension, route=oral.
JNJ-47910382 administered on Day 1.
Type=exact number, unit=mg, number=200, form=tablet, route=oral.
JNJ-47910382 administered on Day 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum plasma concentration (Cmax)
Time Frame: Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
|
Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
|
Time to reach the maximum plasma concentration (Tmax)
Time Frame: Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
|
Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
|
Area under the plasma concentration-time curve (AUC)
Time Frame: Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
|
Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events
Time Frame: Up to 58 days
|
Up to 58 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
August 8, 2012
First Submitted That Met QC Criteria
August 8, 2012
First Posted (Estimate)
August 10, 2012
Study Record Updates
Last Update Posted (Estimate)
July 24, 2013
Last Update Submitted That Met QC Criteria
July 22, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR100881
- 47910382HPC1004 (Other Identifier: Janssen R&D Ireland)
- 2012-002341-38 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Participants
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
PfizerNot yet recruiting
-
Insmed IncorporatedRecruitingHealthy ParticipantsUnited States
-
Aeovian Pharmaceuticals, Inc.RecruitingHealthy ParticipantsAustralia
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRecruitingHealthy ParticipantsChina
-
CelgeneRecruitingHealthy ParticipantsUnited States
-
Bristol-Myers SquibbRecruiting
-
AstraZenecaParexelRecruiting
-
ProMis Neurosciences, IncRecruiting
-
Novo Nordisk A/SRecruiting
Clinical Trials on JNJ-47910382 (suspension)
-
Janssen R&D IrelandTerminated
-
Janssen R&D IrelandCompletedHepatitis C Virus InfectionGermany
-
Janssen R&D IrelandTerminatedChronic Hepatitis C InfectionGermany
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCWithdrawn
-
Janssen Research & Development, LLCRecruitingLymphoma, Non-HodgkinDenmark, Israel, Spain, Australia
-
Janssen-Cilag International NVCompleted
-
Janssen Research & Development, LLCCompleted