A Study of JNJ-56136379 in Healthy Participants

NCT ID: NCT04853524

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2021-07-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

JNJ-56136379 tablets will be administered orally.

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

Intervention Type: DRUG

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

Interventions

JNJ-56136379

JNJ-56136379 tablets will be administered orally.

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

Biktarvy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Other Identifiers

56136379HPB1012

Identifier Type: OTHER

Identifier Source: secondary_id

CR108977

Identifier Type: -

Identifier Source: org_study_id