A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: JNJ-61393215
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
57 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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)
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Double Blind
57 participants in 12 patient groups
Part 1 (Single Ascending Dose [SAD]): Cohort 1
Experimental group
Description:
Participants will receive single oral dose of JNJ-61393215 145 milligram (mg) suspension or matching placebo on day 1, under fasted conditions.
Treatment:
Drug: Placebo
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 1 SAD: Cohort 2
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 3: Treatment Sequence CDEF
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 3: Treatment Sequence DFCE
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 3: Treatment Sequence ECFD
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 3: Treatment Sequence FEDC
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 4: Treatment Sequence GHIJ
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 4: Treatment Sequence HJGI
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 4: Treatment Sequence IGJH
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 2 Cohort 4: Treatment Sequence JIHG
Experimental group
Description:
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.
Treatment:
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 3 Cohort 5: Multiple Ascending Dose
Experimental group
Description:
Participants will receive oral JNJ-61393215 145 mg suspension or matching placebo once daily for 7 days under fasted conditions.
Treatment:
Drug: Placebo
Drug: JNJ-61393215
Drug: JNJ-61393215
Part 3 Cohort 6: Multiple Ascending Dose
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: JNJ-61393215
Drug: JNJ-61393215
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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