A Study of JNJ-56136379 in Healthy Participants

NCT04853524 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: CR10897756136379HPB1012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC)

  Plasma samples will be analyzed to determine concentrations of BIC and FTC.

  Up to Day 25

• Plasma Concentration of Tenofovir Alafenamide (TAF)

  Plasma samples will be analyzed to determine concentrations of TAF.

  Up to Day 20

• Plasma Concentration of JNJ-56136379

  Plasma samples will be analyzed to determine concentrations of JNJ-56136379.

  Up to Day 20

• 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 Outcomes (2)

• 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

  Up to Day 55

• Number of Participants with AEs as a Measure of Safety and Tolerability of JNJ-56136379

  Up to Day 55

Study Arms (1)

Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379

EXPERIMENTAL

Participants will receive a single oral dose of the combination of BIC plus FTC plus TAF tablet on Day 1. Multiple oral doses of JNJ-56136379 once daily on Day 6 to Day 24. A single oral dose of the combination of BIC plus FTC plus TAF tablet on Day 20.

Drug: JNJ-56136379; Drug: Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)

Interventions

JNJ-56136379 DRUG

JNJ-56136379 tablets will be administered orally.

Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379

Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) DRUG

A combination of BIC, FTC and TAF will be administered orally.

Also known as: Biktarvy

Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Interventions

JNJ-56136379; bictegravir; imidazole mustard; Racivir; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: May 6, 2021
• Primary Completion: June 15, 2021
• Study Completion: July 30, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share