A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants

NCT ID: NCT03649997

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2018-12-14

Brief Summary

The purpose of this 3 part study are; Part 1: to investigate the pharmacokinetic (PK), safety and tolerability of JNJ-61393215 suspension (ascending dose levels) after single oral dose administration under fasted conditions, Part 2: to evaluate the relative bioavailability of a solid JNJ-61393215 capsule formulation compared to a suspension of JNJ-61393215 under fasted conditions, and the effect of food on the PK of the solid JNJ-61393215 capsule formulation, Part 3: to investigate the PK, safety, and tolerability of JNJ-61393215 suspension (ascending dose levels) after 7 days of once daily dosing in under fasted conditions.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Part 1 (Single Ascending Dose [SAD]): Cohort 1

Participants will receive single oral dose of JNJ-61393215 145 milligram (mg) suspension or matching placebo on day 1, under fasted conditions.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

Placebo

Intervention Type: DRUG

Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.

Part 1 SAD: Cohort 2

Participants will receive single oral dose of JNJ-61393215 225 mg suspension or matching placebo on day 1 under fasted conditions. Dose in this cohort will be determined based on safety and PK data of cohort 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

Placebo

Intervention Type: DRUG

Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.

Part 2 Cohort 3: Treatment Sequence CDEF

Participants will receive single oral dose of JNJ-61393215 30 mg suspension under fasted condition (Treatment C) in Period 1, then participants will receive single oral dose of JNJ-61393215 30 mg capsule under fasted condition (Treatment D) in Period 2, single oral dose of JNJ-61393215 30 mg capsule with high fat/high-calorie breakfast (Treatment E) in Period 3 followed by single oral dose of JNJ-61393215 30 mg capsule with standardized breakfast (Treatment F) in Period 4, on day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 2 Cohort 3: Treatment Sequence DFCE

Participants will receive Treatment D in Period 1, then Treatment F in Period 2, then Treatment C in Period 3 followed by Treatment E in Period 4 on Day 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 2 Cohort 3: Treatment Sequence ECFD

Participants will receive Treatment E in Period 1, then Treatment C in Period 2, then Treatment F in Period 3 followed by Treatment D in Period 4 on Day 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 2 Cohort 3: Treatment Sequence FEDC

Participants will receive Treatment F in Period 1, then Treatment E in Period 2, then Treatment D in Period 3 followed by Treatment C in Period 4 on Day 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 2 Cohort 4: Treatment Sequence GHIJ

Participants will receive single oral dose of JNJ-61393215 suspension under fasted condition (Treatment G) in Period 1, then participants will receive single oral dose of JNJ-61393215 capsule under fasted condition (Treatment H) in Period 2, single oral dose of JNJ-61393215 capsule with high fat/high-calorie breakfast (Treatment I) in Period 3 followed by single oral dose of JNJ-61393215 capsule with standardized breakfast (Treatment J) in Period 4, on day 1 of each treatment period. There will be a washout period of at least 7 days between study drug intake in subsequent treatment periods. Dose in this cohort will be based on the results obtained in Part 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 2 Cohort 4: Treatment Sequence HJGI

Participants will receive Treatment H in Period 1, then Treatment J in Period 2, then Treatment D in Period G followed by Treatment I in Period 4 on Day 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 2 Cohort 4: Treatment Sequence IGJH

Participants will receive Treatment I in Period 1, then Treatment G in Period 2, then Treatment J in Period 3 followed by Treatment H in Period 4 on Day 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 2 Cohort 4: Treatment Sequence JIHG

Participants will receive Treatment J in Period 1, then Treatment I in Period 2, then Treatment H in Period 3 followed by Treatment G in Period 4 on Day 1.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Part 3 Cohort 5: Multiple Ascending Dose

Participants will receive oral JNJ-61393215 145 mg suspension or matching placebo once daily for 7 days under fasted conditions.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

Placebo

Intervention Type: DRUG

Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.

Part 3 Cohort 6: Multiple Ascending Dose

Participants will receive oral JNJ-61393215 225 mg suspension or matching placebo once daily for 7 days under fasted conditions. Dose may be lowered or increased based on the evaluation of safety and PK of Cohort 5. This dose may be the same as the dose chosen for Cohort 2 (Part 1), or it could be different.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

Placebo

Intervention Type: DRUG

Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.

Interventions

JNJ-61393215

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

Intervention Type: DRUG

Placebo

Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.

Intervention Type: DRUG

JNJ-61393215

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female of non-childbearing potential
• Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (including QT interval corrected for heart rate according to Fridericia's formula [QTcF] less-than or equal to [<=] 450 milliseconds (ms) for males and <= 470 ms for females) performed at screening
• Before enrollment, female participants must be of non-childbearing potential, defined as: a) Postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause, as documented by medical records or physician's notes; b) Permanently sterile - Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
• Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight < than 50 kg at screening
• 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 at screening

Exclusion Criteria

• Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
• Participants has any liver function test (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyltransferase [GGT], alkaline phosphatase [ALP], and bilirubin) at screening more than (>)1.5* upper limit of normal (ULN)
• Participants has estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 61 milliliter (mL) / minute /1.73 per square meter (m^2) at screening
• Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
• Known allergies, hypersensitivity, or intolerance to JNJ-61393215 or its excipients (or lactose)

• 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

PRA Health Sciences

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2018-001944-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

61393215EDI1004

Identifier Type: OTHER

Identifier Source: secondary_id

CR108492

Identifier Type: -

Identifier Source: org_study_id