A Study of JNJ-70075200 in Healthy Participants

NCT ID: NCT04782661

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-09-23

Brief Summary

The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).

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)

Participants will receive an oral solution of JNJ-70075200 or placebo in single ascending doses on Day 1 in cohorts 1, 2, 3, 4, 5a and 6 under fasted condition. Participants in cohort 5a will additionally receive the same study intervention under fed condition (Cohort 5b) after a washout period of at least 7 days.

Group Type: EXPERIMENTAL

JNJ-70075200

Intervention Type: DRUG

JNJ-70075200 solution or solid formulations will be administered orally.

Placebo

Intervention Type: DRUG

Placebo solution will be administered orally.

Part 2: Multiple Ascending Dose (MAD)

After assessment of safety, tolerability and pharmacokinetics data in Part 1, participants will receive an oral solution of JNJ-70075200 or placebo twice daily in Cohorts 1 to 6 for 14 days under fasted/fed condition.

Group Type: EXPERIMENTAL

JNJ-70075200

Intervention Type: DRUG

JNJ-70075200 solution or solid formulations will be administered orally.

Placebo

Intervention Type: DRUG

Placebo solution will be administered orally.

Part 3: Single-dose Oral Solid Formulation (Optional)

Participants will receive oral dose of JNJ-70075200 on Day 1 in Cohort 1 under fasted condition. Part 3 will start after obtaining a formal regulatory/ethical approval.

Group Type: EXPERIMENTAL

JNJ-70075200

Intervention Type: DRUG

JNJ-70075200 solution or solid formulations will be administered orally.

Interventions

JNJ-70075200

JNJ-70075200 solution or solid formulations will be administered orally.

Intervention Type: DRUG

Placebo

Placebo solution will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant
• Participants be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
• No history of pathogen driven cancers (carcinomas, sarcomas, gastric cancer, bladder cancer,Cholangiocarcinoma)
• Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range 18 and 30 kilograms per square meter (kg/m^2) (BMI = weight/height^2) (inclusive)
• All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening

Exclusion Criteria

• Participants having a history of liver or renal insufficiency (estimated creatinine clearance [CL] below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Participants having a QT interval corrected according to Fridericia's formula (QTcF) greater than (>) 450 milliseconds (msec) for males, and >470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at Day -1
• Known allergies, hypersensitivity, or intolerance to JNJ-70075200 or its excipients
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Participants having a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day -2

• 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

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2020-004946-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

70075200SLE1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108971

Identifier Type: -

Identifier Source: org_study_id