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A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation

A Phase 1, Open-label, 2-panel, Randomized, Crossover Study in Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single 600-mg Dose of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation, Under Fed and Fasted Conditions

NCT02659735•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872 following administration of a single dose as three different concept formulations with that following administration of the current formulation, under both fed and fasted conditions, in healthy adult participants.

Detailed Description

This is a Phase 1, open-label, 2-panel, randomized, crossover study in healthy adult participants to assess the relative bioavailability JNJ-63623872. The study population will consist of 48 healthy adult participants, equally divided over 2 panels: 24 participants in Panel 1 and 24 participants in Panel 2. participants will be randomized within each panel. Participants will not be randomized between panels. Panels 1 and 2 will be performed sequentially. Participants having participated in one panel cannot also participate in the other panel. In Panel 1, during 4 subsequent treatment sessions (Periods I, II, III and IV), each participant will receive 4 treatments (Treatments A, B, C, and D), randomized according to a classical 4 sequence, 4 period Williams design. In Panel 2, during 3 subsequent treatment sessions (Periods I, II and III), each participant will receive 3 treatments (Treatments E, F, and G) randomized according to a classical 6 sequence, 3 period Williams design. Primarily, pharmacokinetic parameters will be evaluated. Participants' safety will be monitored throughout the study.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A female participants must be either: a) Not of childbearing potential: postmenopausal greater than (\>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \>40 international Unit/Liter (IU/L); OR b) Permanently sterilized (example, bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or otherwise incapable of becoming pregnant; OR c) If of childbearing potential and heterosexually active, be practicing an effective method of contraception before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 90 days after receiving the last dose of study drug
•A female participant (except if postmenopausal) must have a negative serum beta human chorionic gonadotropin (beta hCG) pregnancy test at Screening and on Day -1
•Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kilogram per meter\^2 (kg/m\^2) (extremes included)
•Participants must have a blood pressure (after the participant is supine for at least 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
•Participants must be non-smokers for at least 3 months prior to Screening

Exclusion Criteria

•Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, 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), history of risk factors for Torsade de Pointes syndrome (example, 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 with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
•Participant has taken any disallowed therapies before the planned first intake of study drug

Locations (1)

Antwerp, Belgium

Key Dates

Start Date

December 1, 2015

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

February 3, 2025

Enrollment

ACTUAL participants

Conditions

Influenza A Virus

Interventions

JNJ-63623872 300 milligram (mg)

DRUG

JNJ-63623872 600 mg

DRUG

JNJ-63623872 600 mg

DRUG

JNJ-63623872 600 mg

DRUG

Safety and Immunogenicity of Live Attenuated Influenza H5N2

NCT01841918

Influenza Due to Influenza A Virus Subtype H5N2

View study

COMPLETEDPHASE1

An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Prime-Boost Intervals With Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc.) Administered Alone or Following Re...

NCT01086657

Influenza A Virus, H5N1 Subtype

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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