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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:11/11/2018
Start Date:July 31, 2018
End Date:September 19, 2018

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An Open-Label, Fixed-Sequence Study in Healthy Subjects to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215

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.


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
We found this trial at
1
site
Salt Lake City, Utah 84124
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Salt Lake City, UT
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