A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01662661
First received: August 8, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Healthy Participants
Drug: JNJ-47910382 (suspension)
Drug: JNJ-47910382 (tablet)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 58 days ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: JNJ-47910382 (suspension)
Type=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.
Drug: JNJ-47910382 (tablet)
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.
Drug: JNJ-47910382 (suspension)
Type=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.
Drug: JNJ-47910382 (tablet)
Type=exact number, unit=mg, number=200, form=tablet, route=oral. JNJ-47910382 administered on Day 1.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662661

Locations
Belgium
Antwerp, Belgium
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01662661     History of Changes
Other Study ID Numbers: CR100881, 47910382HPC1004, 2012-002341-38
Study First Received: August 8, 2012
Last Updated: July 22, 2013
Health Authority: Belgium: FAGG (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten)
Belgium: Ethics Committee
United States: Food and Drug Administration

Keywords provided by Janssen R&D Ireland:
Healthy participants
Hepatitis C
Relative bioavailability
Bioavailability
Pharmacokinetics
JNJ-47910382

ClinicalTrials.gov processed this record on August 21, 2014