Completed

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

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What is being tested

JNJ-47910382 (suspension)

+ JNJ-47910382 (tablet)

+ JNJ-47910382 (suspension)

Drug
Who is being recruted

Blood-Borne Infections+8

+ Communicable Diseases

+ Digestive System Diseases

From 18 to 55 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorJanssen R&D Ireland
Last updated: July 24, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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).

NCT01662661
Principal SponsorJanssen R&D Ireland
Last updated: July 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, Viral, HumanInfectionsLiver DiseasesRNA Virus InfectionsVirus DiseasesFlaviviridae InfectionsHepatitis C

Criteria

5 inclusion criteria required to participate
Female participants must have a negative serum pregnancy test (at screening)

If a female, must be postmenopausal or surgically sterile

Must be a non-smoker for at least 3 months prior to selection

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)

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5 exclusion criteria prevent from participating
A positive human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2) test (at screening)

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

Have a positive urine drug test or alcohol breath test (at screening)

Hepatitis A, B or C infection (at screening)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Antwerp, BelgiumOpen in Google Maps
CompletedOne Study Center