Salt Lake City, Utah 84124

  • Healthy

Purpose:

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.


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


Study is Available At:


Original ID:

CR108479


NCT ID:

NCT03593954


Secondary ID:

61393215EDI1003


Study Acronym:


Brief Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Janssen Research & Development, LLC


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Study Dates

Start Date:July 31, 2018
Completion Date:September 20, 2018
Completion Type:Anticipated
Primary Completion Date:September 20, 2018
Primary Completion Type:Anticipated
Verification Date:September 2018
Last Changed Date:September 21, 2018
First Received Date:July 11, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of Participants with Adverse Event as a Measure of Safety and Tolerability
Time Frame:Approximately 8 weeks
Safety Issues:False
Description:An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome Type:Primary Outcome
Measure:First-Order Rate Constant Associated with the Terminal Portion of the Curve [Lambda(z)] of JNJ-61393215
Time Frame: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); Da
Safety Issues:False
Description:Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Outcome Type:Primary Outcome
Measure:Area Under Plasma-Concentration Curve from Time 0 to Infinite Time (AUCinfinity) of JNJ-61393215
Time Frame: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); Da
Safety Issues:False
Description:AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantif
Outcome Type:Primary Outcome
Measure:Area Under Plasma-Concentration Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of JNJ-61393215
Time Frame: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); Da
Safety Issues:False
Description:AUClast is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Outcome Type:Primary Outcome
Measure:Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393215
Time Frame: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); Da
Safety Issues:False
Description:Tlast is the time to last observed quantifiable plasma concentration.
Outcome Type:Primary Outcome
Measure:Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393215
Time Frame: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); Da
Safety Issues:False
Description:Tmax is the time to reach maximum plasma concentration.
Outcome Type:Primary Outcome
Measure:Last Quantifiable Plasma Concentration (Clast) of JNJ-61393215
Time Frame: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); Da
Safety Issues:False
Description:Clast is the last quantifiable Plasma concentration.
Outcome Type:Primary Outcome
Measure:Maximum Plasma Concentration (Cmax) of JNJ-61393215
Time Frame: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); Da
Safety Issues:False
Description:Cmax is the maximum observed plasma concentration.

Study Interventions

Intervention Type:Drug
Name:Ritonavir
Description:Participants will receive 100 mg of ritonavir tablet orally.
Arm Name:JNJ-61393215 2 mg + Ritonavir 100 mg
Intervention Type:Drug
Name:JNJ-61393215
Description:Participants will receive 2 oral administrations of 2 mg JNJ-61393215 as oral suspension.
Arm Name:JNJ-61393215 2 mg + Ritonavir 100 mg

Study Arms

Study Arm Type:Experimental
Arm Name:JNJ-61393215 2 mg + Ritonavir 100 mg
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Janssen Research & Development, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 23, 2021

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