Clinical trial NCT03593954: A Study to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215 in Healthy Participants
Official title: An Open-Label, Fixed-Sequence Study in Healthy Subjects to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of JNJ-61393215
timeFrame: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
measure: Last Quantifiable Plasma Concentration (Clast) of JNJ-61393215
timeFrame: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
measure: Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393215
timeFrame: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
measure: Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393215
timeFrame: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
measure: Area Under Plasma-Concentration Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of JNJ-61393215
timeFrame: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
measure: Area Under Plasma-Concentration Curve from Time 0 to Infinite Time (AUCinfinity) of JNJ-61393215
timeFrame: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
measure: First-Order Rate Constant Associated with the Terminal Portion of the Curve [Lambda(z)] of JNJ-61393215
timeFrame: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
Secondary outcomes:
measure: Number of Participants with Adverse Event as a Measure of Safety and Tolerability
timeFrame: Approximately 8 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA International
state: Utah
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: