Clinical trial NCT01662661: A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy participants
Hepatitis C
Relative bioavailability
Bioavailability
Pharmacokinetics
JNJ-47910382
Lead sponsor: Janssen R&D Ireland
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 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)
measure: Time to reach the maximum plasma concentration (Tmax)
timeFrame: 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)
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 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:
measure: Number of participants with adverse events
timeFrame: Up to 58 days
Other outcomes:
Locations:
city: Antwerp
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: