A Study of JNJ-75105186 in Healthy Japanese and Chinese Participants

NCT05159128 | Withdrawn Phase 1

• 2 other identifiers: CR10910775105186CRD1001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-75105186 after single ascending oral dose administration in healthy Japanese participants and after single oral dose administration in healthy Chinese participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Part 1 and 2: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  An 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.

  Up to 6 weeks

• Part 1 and 2: Plasma Concentration of JNJ-75105186

  Plasma samples will be analyzed to determine concentrations of JNJ-75105186 using a validated, specific and sensitive method.

  Predose up to 48 hours postdose (up to Day 3)

Study Arms (2)

Part 1: Single Ascending Dose (SAD) Cohorts

EXPERIMENTAL

Healthy Japanese participants will receive JNJ-75105186 or matching placebo orally in Cohorts 1-3.

Drug: JNJ-75105186; Other: Placebo

Part 2: Single Dose (SD) Cohort

EXPERIMENTAL

Healthy Chinese participants will receive JNJ-75105186 or matching placebo orally in Cohort 4.

Drug: JNJ-75105186; Other: Placebo

Interventions

JNJ-75105186 DRUG

JNJ-75105186 will be administered orally in Part 1 and 2.

Part 1: Single Ascending Dose (SAD) Cohorts; Part 2: Single Dose (SD) Cohort

Placebo OTHER

Matching placebo to JNJ-75105186 will be administered orally in Parts 1 and 2.

Part 1: Single Ascending Dose (SAD) Cohorts; Part 2: Single Dose (SD) Cohort

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
• Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, blood coagulation, 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. This determination must be recorded in the participant's source documents and initialed by the investigator
• Body weight not less than 50 kilograms (kg) and body mass index within the range 18 to 30 kg per meter square (kg/m\^2) (inclusive)
• A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 90 days after receiving the administration of study intervention
• Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study
• It is recommended that participants are up to date on age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) Coronavirus Disease of 2019 (COVID-19) vaccines recently prior to study entry, follow applicable local vaccine labeling, guidelines, and standards of care for participants receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrollment

You may not qualify if:

• Had major surgery, (example, requiring general anesthesia) within 3 months before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 12 weeks after the last dose of study intervention administration
• History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
• History of bleeding associated with procedures such as endoscopy or phlebotomy; or use of medications such as nonsteroidal anti-inflammatory drugs or aspirin within 28 days prior to screening or planned use during the study
• Preplanned surgery or procedures that would interfere with the conduct of the study
• Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  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: December 6, 2021
• First Posted: December 15, 2021
• Study Start: November 15, 2021
• Primary Completion: April 2, 2022
• Study Completion: April 2, 2022
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)