TerminatedNCT04236453Updated Jul 7, 2020

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

A Phase 1 interventional study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC and Darunavir in Healthy, sponsored by Janssen Pharmaceutica N.V., Belgium. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Janssen Pharmaceutica N.V., Belgium · Phase 1, Interventional, and Other

Why this study was terminated

COVID-19 pandemic impacted the BE assessment of the trial. The clinical team decided to terminate the trial in order to start a new pivotal BE trial

Phase: Phase 1
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI) when administered as an fixed dose combination (FDC) (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide [D/C/F/TAF]) compared to the co-administration as the separate commercial formulations (DRV and F/TAF and COBI), under fed conditions, in healthy participants.

Conditions studied

Healthy

In context

Lead sponsor

Janssen Pharmaceutica N.V., Belgium is the lead sponsor of 58 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Must be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
Participant must be healthy on the basis of clinical laboratory test performed at screening. If the results of the serum chemistry panel, 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.
A woman (of childbearing potential) must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test, 4 days or less before dosing of the first treatment period
Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
A 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 at least 90 days after receiving the last dose of study drug, a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person (male subject should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak); must agree not to donate sperm for the purpose of reproduction.
Must be willing and able to adhere to the prohibitions and restrictions specified in the study protocol

Exclusion criteria

Exclusion Criteria:

Has history or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, hepatic or renal insufficiency (for example, estimated creatinine clearance below less than [\<] 90 milliliter per minute [mL/min] at screening), gastrointestinal disease (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Had one or more of the laboratory abnormalities at screening as outlined in the protocol by the Division of Acquired immunodeficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events and in accordance with the normal ranges of the clinical laboratory
Clinically significant abnormalities during physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator
With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, methadone, benzodiazepines, methamphetamine, tetrahydrocannabinol, phencyclidine, and tricyclic antidepressants) either at screening or on Day 1 of each treatment period

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
Treatment A
Participants will receive Treatment A (a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide \[D/C/F/TAF\] as one fixed dose combination \[FDC\] tablet under fed condition on Day 1) as per assigned treatment sequence (Treatment sequence ABBA or BAAB). A wash out period of at least 7 days will be maintained between each treatment period.
Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC · Drug: Darunavir · Drug: Emtricitabine/Tenofovir Alafenamide · Drug: Cobicistat
Active comparator
Treatment B
Participants will receive Treatment B (a single dose of Darunavir \[DRV\], Emtricitabine/Tenofovir Alafenamide \[F/TAF\] and Cobicistat \[COB\] tablet under fed condition on Day 1) as per assigned treatment sequence (Treatment sequence ABBA or BAAB). A washout period of at least 7 days will be maintained between each treatment period.
Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC · Drug: Darunavir · Drug: Emtricitabine/Tenofovir Alafenamide · Drug: Cobicistat

Interventions

DrugDarunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally on Day 1 of treatment periods with Treatment A.
Also known as: TMC114/JNJ-48763364/JNJ-35807551/JNJ-63625328
DrugDarunavir
Participants will receive a single dose of Darunavir orally on Day 1 of treatment periods with Treatment B.
DrugEmtricitabine/Tenofovir Alafenamide
Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally on Day 1.
DrugCobicistat
Participant will receive a single dose of Cobicistat tablet orally on Day 1.

What researchers measure

Primary outcomes

Maximum Observed Analyte Concentration (Cmax) of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide
Cmax is the maximum observed analyte concentration.
Time frame: Up to 72 hours post-dose
Area Under the Analyte Concentration-time Curve from time Zero to Last Quantifiable time (AUC[0-last]) of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide
AUC(0-last) is the area under the analyte concentration-time curve of from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
Time frame: Up to 72 hours post-dose

Secondary outcomes

Area Under the Analyte Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide
AUC (0-infinity) is the area under the analyte concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the analyte concentration-time curve from time zero to last quantifiable time, C(last) is the last observed measurable concentration, and lambda(z) is elimination rate constant.
Time frame: Up to 72 hours post-dose
Cmax of Cobicistat
Cmax is the maximum observed analyte concentration of Cobicistat.
Time frame: Up to 72 hours post-dose
AUC(0-last) of Cobicistat
AUC(0-last) is the area under the analyte concentration-time curve of from time 0 to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation.
Time frame: Up to 72 hours post-dose
Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: From signing of the Informed consent form (ICF) till the last study-related activity (up to 10 weeks)

Study locations

1 site

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ, Netherlands

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& 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

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04236453
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Responsible party: Sponsor
First posted: Jan 22, 2020
Start date: Jan 23, 2020
Primary completion: Apr 10, 2020
Completion: Apr 10, 2020
Last update: Jul 7, 2020

Study contacts

Janssen Pharmaceutica N.V., Belgium Clinical Trials

study director · Janssen Pharmaceutica N.V., Belgium

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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