A Study of JNJ-70075200 in Healthy Participants

NCT04782661 | Withdrawn Phase 1

• 3 other identifiers: CR1089712020-004946-1270075200SLE1001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  Up to 1 year and 1 month

• Percentage of Participants with Serious Adverse Events (SAEs)

  A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  Up to 1 year and 1 month

• Number of Participants with Clinically Significant Changes in Vital Signs

  Number of participants with clinically significant changes in vital signs will be assessed.

  Up to 1 year and 1 month

• Number of Participants with Clinically Significant Changes in Physical Examination

  Number of participants with clinically significant changes in physical examination will be assessed.

  Up to 1 year and 1 month

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.

  Up to 1 year and 1 month

• Change From Baseline in QTc Interval

  Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).

  Baseline, up to 1 year and 1 month

• Change from Baseline in Heart Rate (HR)

  Change from baseline in HR will be measured by ECG.

  Baseline, up to 1 year and 1 month

• Change from Baseline in QRS Interval

  Change from baseline in QRS interval will be measured by ECG.

  Baseline, up to 1 year and 1 month

• Change from Baseline in PR Interval

  Change from baseline in PR interval will be measured by ECG.

  Baseline, up to 1 year and 1 month

• Change From Baseline in QT Interval

  Change from baseline in QT interval will be measured by ECG.

  Baseline, up to 1 year and 1 month

Secondary Outcomes (12)

• Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time

  Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)

• Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)

  Predose, up to 72 hours postdose (up to Day 4)

• Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)

  Up to 1 year and 1 month

• Part 1 and 3: Percentage of Participants with SAEs (Food Effect)

  Up to 1 year and 1 month

• Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)

  Up to 1 year and 1 month

Study Arms (3)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

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.

Drug: JNJ-70075200; Drug: Placebo

Part 2: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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.

Drug: JNJ-70075200; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-70075200

Interventions

JNJ-70075200 DRUG

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

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD); Part 3: Single-dose Oral Solid Formulation (Optional)

Placebo DRUG

Placebo solution will be administered orally.

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trials

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2022
• Primary Completion: May 9, 2022
• Study Completion: September 23, 2022
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)