A Study to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215 in Healthy Participants

NCT ID: NCT03593954

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2018-09-19

Brief Summary

The primary purpose of this study is to assess the effect of ritonavir, on the single-dose pharmacokinetics (PK) of JNJ-61393215 in healthy participants.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

JNJ-61393215 2 mg + Ritonavir 100 mg

Participants will receive suspension of JNJ-61393215 2 mg (Day 1 and 5) orally and tablet of Ritonavir 100 mg twice a Day (Day 4-14) orally.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

Participants will receive 2 oral administrations of 2 mg JNJ-61393215 as oral suspension.

Ritonavir

Intervention Type: DRUG

Participants will receive 100 mg of ritonavir tablet orally.

Interventions

JNJ-61393215

Participants will receive 2 oral administrations of 2 mg JNJ-61393215 as oral suspension.

Intervention Type: DRUG

Ritonavir

Participants will receive 100 mg of ritonavir tablet orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male participants or female participants of non-childbearing potential between 18 and 55 years of age, inclusive
• Before enrollment, female participants must be of non-childbearing potential; postmenopausal state is defined as no menses for 12 months without an alternative medical cause, as documented by medical records or physician's notes and Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
• Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height^2) and body weight not less than 50 kg
• Participant must be healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
• 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

Exclusion Criteria

• Participant has any clinically significant abnormal findings in physical examination, vital signs or 12-lead ECG [including QT corrected according to Fridericia's formula (QTcF) greater than (>) 450 milliseconds (msec) and less than or equal to (=<) 470 (milliseconds) msec for females, Left Bundle Branch Block, atrioventricular (AV) Block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator (ICD)] at screening or admission (up to Day 1 predose), which in the opinion of the investigator are not appropriate and reasonable for the population under study
• Participant has a history of or current liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
• Participant has any liver function test (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP) and bilirubin at screening >1.5 * ULN (upper limit of normal)
• Participant has estimated glomerular filtration rate (eGFR) less than (<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening (provided by the local laboratory)
• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening

• 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 International

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

61393215EDI1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108479

Identifier Type: -

Identifier Source: org_study_id