Clinical trial NCT02659735: A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza A Virus
Keywords: Influenza A virus
JNJ-63623872
Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-20
Enrollment: 90
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 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 criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
timeFrame: Day 1
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: Day 1
measure: Elimination Rate Constant (Lambda[z])
timeFrame: Day 1
measure: Elimination Half-Life (t1/2)
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to 10 to 14 days after last study drug administration
measure: Taste Questionnaire Assessment
timeFrame: Day 1
measure: Swallowability Assessment
timeFrame: Day 1
Other outcomes:
Locations:
city: Antwerp
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trials
role: STUDY_DIRECTOR
References: