Clinical trial NCT04853524: A Study of JNJ-56136379 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC)
timeFrame: Up to Day 25
measure: Plasma Concentration of Tenofovir Alafenamide (TAF)
timeFrame: Up to Day 20
measure: Plasma Concentration of JNJ-56136379
timeFrame: Up to Day 20
measure: Urine Concentration of BIC, FTC and TAF
timeFrame: Up to Day 22
Secondary outcomes:
measure: 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
timeFrame: Up to Day 55
measure: Number of Participants with AEs as a Measure of Safety and Tolerability of JNJ-56136379
timeFrame: Up to Day 55
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: