A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants

May 24, 2017 updated by: Janssen-Cilag International NV

A Phase 1, Open-label, Randomized, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation

The purpose of this study is to assess the rate and extent of absorption of JNJ63623872 following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept single agent tablet formulations compared to the administration of 2*300 mg JNJ63623872 reference tablets, under fasted conditions in healthy adult participants and to assess the rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a single oral dose of 2*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose combination (FDC) tablet formulation compared to the coadministration of 2*300 mg JNJ63623872 tablets (reference formulation) and 1*75 mg oseltamivir capsule, under fasted conditions in healthy adult participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

  • Belgium
      • Antwerp, Belgium, 2060
        • SGS Life Science Services

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A female participant must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and on Day -1 in each treatment period
  • Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
  • A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug
  • Participant must have a body mass index (BMI), weight kilogram per height square meter square [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (extremes included) at screening. The minimum weight will be 50.0 kilogram (kg)
  • Participant must have a blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
  • Participant must be non-smoker for at least 3 months prior to screening

Exclusion Criteria:

  • Participant has history or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, diabetes mellitus, hepatic or renal insufficiency, gastrointestinal disease, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Participant with a past history of heart arrhythmias (extrasystoli, tachycardia at rest), or history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
  • Participant has known allergy to heparin or history of heparin induced thrombocytopenia
  • Participant has donated blood or blood products or had substantial loss of blood (more than 500 milliliter (mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
  • A woman who is pregnant, or breast-feeding, or planning to become pregnant during this study, or a woman of childbearing potential who is unwilling to use acceptable methods of contraception
  • Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
  • Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection, or tests positive for HIV-1 or -2 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: Panel 1: Group 1
Participants will receive Treatment A (JNJ-63623872 600 milligram (mg) (2*300 mg) oral tablets [reference]) followed by Treatment B (JNJ- 63623872 600 mg (2*300 mg) concept oral tablet formulation 1 (test 1) and then Treatment C (JNJ-63623872 600 mg (2*300 mg) concept oral tablet formulation 2 (test 2). Each treatment period will be separated 7 days washout period.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Experimental: Panel 1: Group 2
Participants in Group 2 will receive Treatment A followed by Treatment C and then Treatment B with a washout period of minimum 7 days.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Experimental: Panel 1: Group 3
Participants in Group 3 will receive Treatment B followed by Treatment A and then Treatment C with a washout period of minimum 7 days.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Experimental: Panel 1: Group 4
Participants in Group 4 will receive Treatment B followed by Treatment C and then Treatment A with a washout period of minimum 7 days.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Experimental: Panel 1: Group 5
Participants in Group 5 will receive Treatment C followed by Treatment A and then Treatment B with a washout period of minimum 7 days.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Experimental: Panel 1: Group 6
Participants in Group 6 will receive Treatment C followed by Treatment B and then Treatment A with a washout period of minimum 7 days.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Experimental: Panel 2: Group 7
Participants in Group 7 will receive Treatment D [JNJ-63623872/37.5 mg Oseltamivir oral fixed dose combination (FDC) tablet concept formulation (test 3)] followed by Treatment E (JNJ-63623872 600 mg, administered as 2*300 mg and Oseltamivir 75 mg, administered as 1*75 mg). Both treatment periods will be separated with a minimum of 7 days washout period.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Drug: Oseltamivir
Participants will receive Oseltamivir 75 mg (1*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.
Experimental: Panel 2: Group 8
Participants in Group 8 will receive Treatment E followed by Treatment D with a washout period of minimum 7 days.
Drug: JNJ-63623872
Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
Drug: Oseltamivir
Participants will receive Oseltamivir 75 mg (1*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
The Plasma Concentration (Cmax) is defined as maximum observed plasma concentration.
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration Time (AUC [0-Last])
Time Frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
AUC last is area under the plasma concentration-time curve from time zero to last quantifiable concentration time.
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time Frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
Apparent Terminal Elimination Rate Constant (Lambda [z])
Time Frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
Lambda (z) is defined as apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve.
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
Apparent Terminal Elimination Half-life (t1/2)
Time Frame: Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Predose, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h and 96 hours postdose on Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to follow-up (within 10 to 14 days after last dose)
Safety and Tolerability
Up to follow-up (within 10 to 14 days after last dose)
Taste Questionnaire Assessment
Time Frame: Day 1
A taste questionnaire will be completed by the participants of Panel 2, group 7 within 5 to 15 minutes after intake of the FDC tablet (Treatment E) to evaluate the taste of the oral FDC tablet formulation under fasted conditions. The Taste questionnaire consists of 4 parts (sweetness, bitterness, flavour and overall); each parts is scored on 4 points , i.e. none, weak, moderate and strong.
Day 1
Swallowability Assessment
Time Frame: Day 1
Swallowability will be assessed in participants of Panel 2 group 7 on a scale of 1-7; how difficult/easy was it to swallow this tablet. In the scale 0=very difficult and 7=very easy.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag International NV

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 (Actual)

February 14, 2017

Primary Completion (Actual)

April 14, 2017

Study Completion (Actual)

April 14, 2017

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108252
  • 63623872FLZ1011 (Other Identifier: Janssen-Cilag International NV)
  • 2016-004504-62 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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