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

NCT ID: NCT04236453

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2020-04-10

Brief 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

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC

Intervention Type: DRUG

Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally on Day 1 of treatment periods with Treatment A.

Darunavir

Intervention Type: DRUG

Participants will receive a single dose of Darunavir orally on Day 1 of treatment periods with Treatment B.

Emtricitabine/Tenofovir Alafenamide

Intervention Type: DRUG

Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally on Day 1.

Cobicistat

Intervention Type: DRUG

Participant will receive a single dose of Cobicistat tablet orally on Day 1.

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.

Group Type: ACTIVE_COMPARATOR

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC

Intervention Type: DRUG

Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally on Day 1 of treatment periods with Treatment A.

Darunavir

Intervention Type: DRUG

Participants will receive a single dose of Darunavir orally on Day 1 of treatment periods with Treatment B.

Emtricitabine/Tenofovir Alafenamide

Intervention Type: DRUG

Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally on Day 1.

Cobicistat

Intervention Type: DRUG

Participant will receive a single dose of Cobicistat tablet orally on Day 1.

Interventions

Darunavir/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.

Intervention Type: DRUG

Darunavir

Participants will receive a single dose of Darunavir orally on Day 1 of treatment periods with Treatment B.

Intervention Type: DRUG

Emtricitabine/Tenofovir Alafenamide

Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally on Day 1.

Intervention Type: DRUG

Cobicistat

Participant will receive a single dose of Cobicistat tablet orally on Day 1.

Intervention Type: DRUG

Other Intervention Names

TMC114/JNJ-48763364/JNJ-35807551/JNJ-63625328

Eligibility Criteria

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

• 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

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

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V., Belgium Clinical Trials

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2019-002245-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TMC114FD2HTX1005

Identifier Type: OTHER

Identifier Source: secondary_id

CR108649

Identifier Type: -

Identifier Source: org_study_id