HealthyPhase 1NCT04853524
A Study of JNJ-56136379 in Healthy Participants
A Phase 1 study testing JNJ-56136379 and Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) in people with Healthy, run by Janssen Research & Development, LLC.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-56136379 and Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2021to 30 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
- Being tested
- JNJ-56136379, Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-56136379Drug
JNJ-56136379 tablets will be administered orally.
Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)Drug
Also called Biktarvy
A combination of BIC, FTC and TAF will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JNJ-56136379; Drug: Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC)
Plasma samples will be analyzed to determine concentrations of BIC and FTC.
Measured: Up to Day 25
Plasma Concentration of Tenofovir Alafenamide (TAF)
Plasma samples will be analyzed to determine concentrations of TAF.
Measured: Up to Day 20
Plasma Concentration of JNJ-56136379
Plasma samples will be analyzed to determine concentrations of JNJ-56136379.
Measured: Up to Day 20
Urine Concentration of BIC, FTC and TAF
Urine samples will be analyzed to determine concentrations of BIC, FTC and TAF.
Measured: 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
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.
Measured: Up to Day 55
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.
Measured: Up to Day 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start6 May 2021
- Primary completion15 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853524
- Sponsor's protocol ID
- CR108977
- Other IDs
- 56136379HPB1012
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853524
- Acronym / sponsor ID
- CR108977
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379 | Experimental | Drug: JNJ-56136379, Drug: Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-56136379JNJ-56136379 tablets will be administered orally. | Drug | Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379 |
| Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)Also: BiktarvyA combination of BIC, FTC and TAF will be administered orally. | Drug | Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) plus JNJ-56136379 |
Primary outcome
Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC)
Time frame: Up to Day 25
Plasma samples will be analyzed to determine concentrations of BIC and FTC.
Plasma Concentration of Tenofovir Alafenamide (TAF)
Time frame: Up to Day 20
Plasma samples will be analyzed to determine concentrations of TAF.
Plasma Concentration of JNJ-56136379
Time frame: Up to Day 20
Plasma samples will be analyzed to determine concentrations of JNJ-56136379.
Urine Concentration of BIC, FTC and TAF
Time frame: Up to Day 22
Urine samples will be analyzed to determine concentrations of BIC, FTC and TAF.
2 secondary outcomes
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
Time frame: Up to Day 55
Number of Participants with AEs as a Measure of Safety and Tolerability of JNJ-56136379
Time frame: Up to Day 55
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-56136379 and Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) in people with Healthy, run by Janssen Research & Development, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of Bictegravir (BIC) and Emtricitabine (FTC) (time frame: Up to Day 25). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.