HealthyPhase 1NCT02984852

Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants

A Phase 1 study testing Darunavir (DRV), Cobicistat (COBI) and Emtricitabine (FTC) in people with Healthy, run by Janssen Scientific Affairs, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Darunavir (DRV), Cobicistat (COBI) and Emtricitabine (FTC)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Dec 2016to Feb 2017
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

Non-smoker for at least 3 months prior to selection
Body mass index (BMI) of 18.0 to 32 kilogram per square meter (kg/m^2), inclusive
Woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening and a negative sensitive urine pregnancy test on Day -1 before the first dose of study drug
Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug
During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a non-vasectomized man who is sexually active with a woman of childbearing potential must agree to use a highly effective barrier method of contraception

Who cannot join

Positive human immunodeficiency virus -1 (HIV-1) or HIV-2 test at screening
Hepatitis A, B, or C infection, confirmed by a positive hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) test, respectively, at screening
History of renal insufficiency
History of significant drug-induced skin reactions (such as, but not limited, to Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and/or erythema multiforme) or history of allergies to drugs (such as, but not limited to, sulfonamides and penicillins)
Previously participated in a multiple-dose study with Darunavir (DRV), Cobicistat (COBI), Emtricitabine (FTC), Tenofovir Alafenamide (TAF), or Tenofovir Disoproxil Fumarate (TDF)

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Tempe, Arizona

Other trials in United States

About this study

Official title: A Single-dose, Open-label, Randomized, Crossover Study to Assess the Relative Bioavailability of the Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Administered Orally as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Subjects

The purpose of this study is to evaluate the single-dose pharmacokinetics and relative bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg, Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with 240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.

Conditions: Healthy
Being tested: Darunavir (DRV), Cobicistat (COBI), Emtricitabine (FTC), Tenofovir Alafenamide (TAF)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Darunavir (DRV)Drug
Darunavir 800 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/TAF(10mg).
Cobicistat (COBI)Drug
Cobicistat 150 milligram (mg) will be taken orally in FDC together with DRV(800mg)/FTC(200mg)/TAF(10mg).
Emtricitabine (FTC)Drug
Emtricitabine 200 milligram (mg) will be taken orally in FDC together with COBI(150mg)/DRV(800mg)/TAF(10mg).
Tenofovir Alafenamide (TAF)Drug
Tenofovir Alafenamide 10 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/DRV(800mg).

Study groups in NCT02984852
Study group	Role	What they receive
Treatment sequence ABC	Experimental	Participants will receive a single oral tablet of darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) Treatment A (whole tablet) as reference in session 1 then Treatment B(split tablet) as test in session 2 followed by Treatment C (crushed tablet mixed in applesauce) as test in session 3 under fed conditions (standardized breakfast) on Day 1 of each treatment session. There will be a washout period of at least 7 days between consecutive drug intakes. Receives: Drug: Darunavir (DRV); Drug: Cobicistat (COBI); Drug: Emtricitabine (FTC); Drug: Tenofovir Alafenamide (TAF)
Treatment sequence ACB	Experimental	Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment A in treatment session 1, then Treatment C in session 2 followed by Treatment B in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes. Receives: Drug: Darunavir (DRV); Drug: Cobicistat (COBI); Drug: Emtricitabine (FTC); Drug: Tenofovir Alafenamide (TAF)
Treatment sequence BCA	Experimental	Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment B in session 1 then Treatment C in session 2 followed by Treatment A in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes. Receives: Drug: Darunavir (DRV); Drug: Cobicistat (COBI); Drug: Emtricitabine (FTC); Drug: Tenofovir Alafenamide (TAF)
Treatment sequence BAC	Experimental	Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment B in session 1 then Treatment A in session 2 followed by Treatment C in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes. Receives: Drug: Darunavir (DRV); Drug: Cobicistat (COBI); Drug: Emtricitabine (FTC); Drug: Tenofovir Alafenamide (TAF)
Treatment sequence CAB	Experimental	Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment C in session 1 then Treatment A in session 2 followed by Treatment B in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes. Receives: Drug: Darunavir (DRV); Drug: Cobicistat (COBI); Drug: Emtricitabine (FTC); Drug: Tenofovir Alafenamide (TAF)
Treatment sequence CBA	Experimental	Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment C in session 1 then Treatment B in session 2 followed by Treatment A in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes. Receives: Drug: Darunavir (DRV); Drug: Cobicistat (COBI); Drug: Emtricitabine (FTC); Drug: Tenofovir Alafenamide (TAF)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration.
Measured: Up to Day 4
Area Under the Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last])
AUC (0-last) is the area under the Plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation.
Measured: Up to Day 4
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Measured: Up to Day 4

Secondary outcomes (4)

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Clinical Laboratory Results as a Measure of Safety and Tolerability
Measured: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Vital Signs as a Measure of Safety and Tolerability
Measured: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Physical Examination Findings as a Measure of Safety and Tolerability
Measured: Screening (21 days ) to End of the study (7 to 10 days after the last dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Feb 2017

First posted7 Dec 2016 (estimated)
Study startDec 2016
Primary completionFeb 2017
Study completionFeb 2017

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.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02984852
Sponsor's protocol ID: CR108258
Other IDs: TMC114FD2HTX1004
Status last verified: Jan 2025
First submitted: 5 Dec 2016
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Open-label, Randomized, Crossover Study to Assess the Relative Bioavailability of the Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Administered Orally as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Subjects
ClinicalTrials.gov ID: NCT02984852
Acronym / sponsor ID: CR108258
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
Study start: Dec 2016 (actual)
Primary completion: Feb 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 7 Dec 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment sequence ABC	Experimental	Drug: Darunavir (DRV), Drug: Cobicistat (COBI), Drug: Emtricitabine (FTC), Drug: Tenofovir Alafenamide (TAF)Participants will receive a single oral tablet of darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) Treatment A (whole tablet) as reference in session 1 then Treatment B(split tablet) as test in session 2 followed by Treatment C (crushed tablet mixed in applesauce) as test in session 3 under fed conditions (standardized breakfast) on Day 1 of each treatment session. There will be a washout period of at least 7 days between consecutive drug intakes.
Treatment sequence ACB	Experimental	Drug: Darunavir (DRV), Drug: Cobicistat (COBI), Drug: Emtricitabine (FTC), Drug: Tenofovir Alafenamide (TAF)Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment A in treatment session 1, then Treatment C in session 2 followed by Treatment B in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes.
Treatment sequence BCA	Experimental	Drug: Darunavir (DRV), Drug: Cobicistat (COBI), Drug: Emtricitabine (FTC), Drug: Tenofovir Alafenamide (TAF)Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment B in session 1 then Treatment C in session 2 followed by Treatment A in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes.
Treatment sequence BAC	Experimental	Drug: Darunavir (DRV), Drug: Cobicistat (COBI), Drug: Emtricitabine (FTC), Drug: Tenofovir Alafenamide (TAF)Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment B in session 1 then Treatment A in session 2 followed by Treatment C in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes.
Treatment sequence CAB	Experimental	Drug: Darunavir (DRV), Drug: Cobicistat (COBI), Drug: Emtricitabine (FTC), Drug: Tenofovir Alafenamide (TAF)Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment C in session 1 then Treatment A in session 2 followed by Treatment B in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes.
Treatment sequence CBA	Experimental	Drug: Darunavir (DRV), Drug: Cobicistat (COBI), Drug: Emtricitabine (FTC), Drug: Tenofovir Alafenamide (TAF)Participants will receive a single oral tablet of D/C/F/TAF [FDC] Treatment C in session 1 then Treatment B in session 2 followed by Treatment A in session 3 under fed conditions (standardized breakfast) on Day 1 with washout period of at least 7 days between consecutive drug intakes.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Non-smoker for at least 3 months prior to selection
Body mass index (BMI) of 18.0 to 32 kilogram per square meter (kg/m^2), inclusive
Woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening and a negative sensitive urine pregnancy test on Day -1 before the first dose of study drug
Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug
During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a non-vasectomized man who is sexually active with a woman of childbearing potential must agree to use a highly effective barrier method of contraception

Key exclusion criteria (5 listed)

Positive human immunodeficiency virus -1 (HIV-1) or HIV-2 test at screening
Hepatitis A, B, or C infection, confirmed by a positive hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) test, respectively, at screening
History of renal insufficiency
History of significant drug-induced skin reactions (such as, but not limited, to Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and/or erythema multiforme) or history of allergies to drugs (such as, but not limited to, sulfonamides and penicillins)
Previously participated in a multiple-dose study with Darunavir (DRV), Cobicistat (COBI), Emtricitabine (FTC), Tenofovir Alafenamide (TAF), or Tenofovir Disoproxil Fumarate (TDF)

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
Darunavir (DRV)Darunavir 800 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/TAF(10mg).	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA
Cobicistat (COBI)Cobicistat 150 milligram (mg) will be taken orally in FDC together with DRV(800mg)/FTC(200mg)/TAF(10mg).	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA
Emtricitabine (FTC)Emtricitabine 200 milligram (mg) will be taken orally in FDC together with COBI(150mg)/DRV(800mg)/TAF(10mg).	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA
Tenofovir Alafenamide (TAF)Tenofovir Alafenamide 10 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/DRV(800mg).	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 4
Cmax is defined as the maximum observed plasma concentration.
Area Under the Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last])
Time frame: Up to Day 4
AUC (0-last) is the area under the Plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation.
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Up to Day 4
The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.

4 secondary outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Clinical Laboratory Results as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Vital Signs as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)
Number of Participants With Physical Examination Findings as a Measure of Safety and Tolerability
Time frame: Screening (21 days ) to End of the study (7 to 10 days after the last dose)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.

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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 Scientific Affairs, LLC Clinical Trial study director

Janssen Scientific Affairs, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Darunavir (DRV), Cobicistat (COBI) and Emtricitabine (FTC) in people with Healthy, run by Janssen Scientific Affairs, LLC at 1 site in United States.

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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Observed Plasma Concentration (Cmax) (time frame: Up to Day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02984852.

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 3 Feb 2025.