A Study of JNJ-56136379 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Open-label Study in Healthy Participants to Investigate the Effect of Multiple-dose JNJ-56136379 on the Single-dose Pharmacokinetics of Bictegravir, Emtricitabine, and Tenofovir Alafenamide

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04853524
• Other study ID #: CR108977
• Secondary ID: 56136379HPB1012
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 6, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of multiple-dose JNJ-56136379 on the single-dose pharmacokinetics (PK) of the combination of bictegravir (BIC), emtricitabine (FTC), tenofovir alafenamide (TAF) in healthy adult participants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities 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

• Healthy on the basis of clinical laboratory tests performed at screening. If the results of the blood biochemistry, blood coagulation, and 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

• Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day -1

• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted

• Must have a normal 12-lead electrocardiogram (ECG) at screening, including: a) predominant sinus rhythm, b) heart rate between 45 and 100 beats per minute (bpm), extremes included, c) QT interval corrected for heart rate (QTc) interval less than or equal to (<=) 450 milliseconds (ms) in male participants/ <= 470 ms in female participants (QT interval corrected according to Fridericia [QTcF]), c) QRS interval of less than (<)120 ms, and d) PR interval <=220 ms

Exclusion Criteria:

• Having donated or lost 1 or more than 1 unit of blood (500 milliliter [mL]) or had any clinically significant abnormal bleeding in the prior 60 days before the planned first administration of a study drug

• Any history of clinically significant skin disease (as judged by the investigator) such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria

• A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

• Current human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening

• Clinically significant history of liver disease or renal dysfunction (estimated creatinine clearance <60 milliliter per minute [mL/min]) at screening

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-56136379
JNJ-56136379 tablets will be administered orally.
• Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
A combination of BIC, FTC and TAF will be administered orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC)	Plasma samples will be analyzed to determine concentrations of BIC and FTC.	Up to Day 25
Primary	Plasma Concentration of Tenofovir Alafenamide (TAF)	Plasma samples will be analyzed to determine concentrations of TAF.	Up to Day 20
Primary	Plasma Concentration of JNJ-56136379	Plasma samples will be analyzed to determine concentrations of JNJ-56136379.	Up to Day 20
Primary	Urine Concentration of BIC, FTC and TAF	Urine samples will be analyzed to determine concentrations of BIC, FTC and TAF.	Up to Day 22
Secondary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of Multiple-dose JNJ-56136379 Without and With a Single dose of Combination of BIC, FTC, and TAF	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 Day 55
Secondary	Number of Participants with AEs as a Measure of Safety and Tolerability of JNJ-56136379	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 Day 55

External Links

•   To learn how to participate in this trial please click here.