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

NCT ID: NCT02659735

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-04-30

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.

Conditions

Influenza A Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panel 1: Treatment ADBC

Participants will receive Treatment A (600 milligram \[mg\] JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 1; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 2; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 3; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel 1: Treatment BACD

Participants will receive Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 1; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 2; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 3; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel I: Treatment CBDA

Participants will receive Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 1; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 2; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 3; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel I: Treatment DCAB

Participants will receive Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 1; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 2; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 3; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel 2: Treatment EFG

Participants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel 2: Treatment FGE

Participants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel 2: Treatment GEF

Participants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel 2: Treatment GFE

Participants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel 2: Treatment FEG

Participants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Panel 2: Treatment EGF

Participants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-63623872 300 milligram (mg)

Intervention Type: DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

JNJ-63623872 600 mg

Intervention Type: DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Interventions

JNJ-63623872 300 milligram (mg)

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

Intervention Type: DRUG

JNJ-63623872 600 mg

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

Intervention Type: DRUG

JNJ-63623872 600 mg

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.

Intervention Type: DRUG

JNJ-63623872 600 mg

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trials

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

63623872FLZ1006

Identifier Type: OTHER

Identifier Source: secondary_id

2015-002299-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108109

Identifier Type: -

Identifier Source: org_study_id