NCT01662661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

1 month

First QC Date

August 8, 2012

Last Update Submit

July 22, 2013

Conditions

Healthy Participants

Keywords

Healthy participantsHepatitis CRelative bioavailabilityBioavailabilityPharmacokineticsJNJ-47910382

Outcome Measures

Primary Outcomes (3)

  • Maximum plasma concentration (Cmax)

    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)

    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)

    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 Outcomes (1)

  • Number of participants with adverse events

    Up to 58 days

Study Arms (2)

Arm AB

EXPERIMENTAL

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)Drug: JNJ-47910382 (tablet)

Arm BA

EXPERIMENTAL

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)Drug: JNJ-47910382 (tablet)

Interventions

JNJ-47910382 (suspension)DRUG

Type=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.

Arm ABArm BA
JNJ-47910382 (tablet)DRUG

Type=exact number, unit=mg, number=200, form=tablet, route=oral. JNJ-47910382 administered on Day 1.

Arm ABArm BA

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

SuspensionsTablets

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 10, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

BE(1)