A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formulation Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of Oral Concept Formulation

NCT ID: NCT02945007

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-08
• Study Completion Date: 2020-01-16

Brief Summary

The purpose of this study is to assess the relative bioavailability of 1 to 3 concept formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678 when administered as a single oral dose of 500 milligram (mg) in healthy adult participants.

Conditions

Healthy

Study Design

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

Study Groups

JNJ-53718678: PART 1

Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and B (novel concept formulation 1), and under fed condition for treatment C (novel concept formulation 1).

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

JNJ-53718678: PART 2

Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and D (novel concept formulation 2), and under fed condition for treatment E (novel concept formulation 2).

Part 2 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

JNJ-53718678: PART 3

Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and F (novel concept formulation 3), and under fed condition for treatment G (novel concept formulation 3).

Part 3 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

JNJ-53718678: PART 4

Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and H (novel concept formulation 4), and under fed condition for treatment I (novel concept formulation 4).

Part 4 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

JNJ-53718678: PART 5

Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and J (novel concept formulation 5), and under fed condition for treatment K (novel concept formulation 5).

Part 5 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

JNJ-53718678: PART 6

Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and L (novel concept formulation 6), and under fed condition for treatment M (novel concept formulation 6).

Part 6 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

JNJ-53718678: PART 7

Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and N (novel concept formulation 7), and under fed condition for treatment O (novel concept formulation 7).

Part 7 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

JNJ-53718678: PART 8

Participants will receive a single dose of JNJ-53718678, 500 mg oral solution under fasted or fed conditions on day 1 for treatment A and P (oral concept formulation 1, 2, 3, 4, 5, 6 or 7) and under fed conditions for treatment Q (oral concept formulation 1, 2, 3, 4, 5, 6 or 7).

Part 8 of the study is optional, might be performed, depending on the interim results of prior parts. One of the concept formulations might be re-evaluated under different feeding conditions.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

Participants will receive JNJ-53718678 under fed or fasted conditions.

Interventions

JNJ-53718678

Participants will receive JNJ-53718678 under fed or fasted conditions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• At Screening, a female participant must be of non-childbearing potential as defined in the protocol
• Female participants must have a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at Screening
• A male participant must be sexually abstinent (defined as refraining from sexual intercourse from Day 1 (day of dosing) until 90 days after study drug intake) or who is sexually active (either heterosexual, including with a pregnant woman, or homosexual) must agree to use a barrier method of contraception (example, condom) from Day 1 (day of dosing) until 90 days after study drug intake
• Participant must have a body mass index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter^2 (kg/m2), extremes included
• Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria

• Participant with a history of or 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 insufficiency, renal dysfunction (calculated creatinine clearance below 60 milliliter per minute (mL/min) at Screening using the Cockroft-Gault equation), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers that it could interfere with the interpretation of the study results should exclude the participant
• Participants with abnormal values for either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (greater than or equal to [>=]1.25 x upper limit of laboratory normal range [ULN])
• Participants with lack of good/reasonable venous access
• Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or, history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
• Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria within 5 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, methadone, benzodiazepines, and hallucinogens) at Screening and on Day -1 of each treatment period

• 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 Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2016-002665-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

53718678RSV1007

Identifier Type: OTHER

Identifier Source: secondary_id

CR108212

Identifier Type: -

Identifier Source: org_study_id