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A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

DRV/COBI FDC

COBI

DRV

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening (results must be available on Day -1 of Treatment Period 1). If there are any abnormalities (other than those listed in inclusion criterion 12 [for blood pressure]), they must be considered not clinically relevant and 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 (results must be available on Day -1 of Treatment Period 1). 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. This determination must be recorded in the participant's source documents and initialed by the investigator
All women must have a negative highly sensitive serum test (beta-human chorionic gonadotropin [beta-hCG]) 4 days or less before dosing of the first treatment period
A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention
Must sign an informed consent form (ICF) indicating that the participant understands the purpose and procedures required for the study and is willing to participate in the study
A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 90 days after last dose

Exclusion Criteria:

History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Clinically significant abnormalities during physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillin's, or drug allergy diagnosed in previous studies with experimental drugs
With a clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Taken any disallowed therapies, concomitant therapy before the planned first dose of study intervention
Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention

Sites / Locations

SGS Belgium NV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment Sequence AB

Treatment Sequence BA

Arm Description

Participants will receive a single oral dose of darunavir (DRV) and cobicistat (COBI) as one fixed dose combination (FDC) tablet dispersed in water (Treatment A [test]) in Treatment Period 1, followed by a single dose DRV suspension and COBI tablet (Treatment B [Reference]) in Treatment Period 2 on Day 1 of each Treatment Period under fed conditions. There will be a washout period of at least 7 days from dosing on Day 1 of each Treatment Period.

Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 on Day 1 of each Treatment Period under fed conditions. There will be a washout period of at least 7 days from dosing on Day 1 of each Treatment Period

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV)

Cmax is defined as the maximum observed plasma concentration of DRV.

Area Under the DRV Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of DRV

AUC (0-last) is the area under the DRV concentration-time curve from time zero to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.

Area Under the DRV Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of DRV

AUC (0-infinity) is the area under the DRV concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Cobicistat (COBI)

Cmax is defined as the maximum observed plasma concentration of COBI.

Area Under the COBI Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of COBI

AUC (0-last) is the area under the COBI concentration-time curve from time zero to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation.

Area Under the COBI Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of COBI

AUC (0-infinity) is the area under the COBI 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 COBI concentration-time curve from time zero to the time of last measurable non-BQL concentration, C(last) is the last observed measurable (non-BQL) concentration, and lambda(z) is apparent terminal elimination rate constant.

Number of Participants With Serious Adverse Events (SAEs)

An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Number of Participants with Abnormalities in Physical Examinations

Number of participants with abnormalities in physical examinations (including skin examination, body weight, height and family history related to skin disease) will be reported.

Number of Participants with Abnormalities in Vital Sign Measurements

Number of participants with abnormalities in vital sign measurements (including temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.

Number of Participants with Abnormalities in Clinical Laboratory Tests

Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and random urine samples) will be reported.

Full Information

NCT ID

NCT05378906

First Posted

May 13, 2022

Last Updated

October 25, 2022

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05378906

Brief Title

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants

Official Title

A Single-dose, Open-label, Randomized, Crossover Pivotal Bioequivalence Study in Healthy Participants to Assess the Bioequivalence of Darunavir 600 mg in the Presence of Cobicistat 90 mg When Administered as a Fixed Dose Combination Tablet (Darunavir/Cobicistat) Compared to the Co-administration of the Separate Available Formulations (Darunavir 100 mg/mL Suspension at a Dose of 600 mg and Cobicistat 90 mg Tablet), Under Fed Conditions

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 7, 2022 (Actual)

Primary Completion Date

September 28, 2022 (Actual)

Study Completion Date

September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the single-dose pharmacokinetic (PK) and bioequivalence of Darunavir (DRV) in the presence of Cobicistat (COBI) when administered as a DRV/COBI fixed dose combination (FDC) tablet dispersed in water compared to the co-administration of the separate available formulations (DRV suspension and COBI tablet) under fed conditions in healthy participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Sequence AB

Arm Type

Experimental

Arm Description

Arm Title

Treatment Sequence BA

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

DRV/COBI FDC

Other Intervention Name(s)

TMC114/JNJ-48763364

Intervention Description

Participants will receive a single oral dose of DRV/COBI FDC tablet dispersed in water as per assigned treatment sequence.

Intervention Type

Drug

Intervention Name(s)

COBI

Other Intervention Name(s)

JNJ-48763364

Intervention Description

Participants will receive a single oral dose of COBI tablet as per assigned treatment sequence.

Intervention Type

Drug

Intervention Name(s)

DRV

Other Intervention Name(s)

TMC114

Intervention Description

Participants will receive single oral dose of DRV suspension as per the assigned treatment sequence.

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV)

Description

Cmax is defined as the maximum observed plasma concentration of DRV.

Time Frame

Pre dose, up to 72 hours post dose (up to Day 4)

Title

Area Under the DRV Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of DRV

Description

Time Frame

Pre dose, up to 72 hours post dose (up to Day 4)

Title

Area Under the DRV Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of DRV

Description

AUC (0-infinity) is the area under the DRV concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).

Time Frame

Pre dose, up to 72 hours post dose (up to Day 4)

Secondary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax) of Cobicistat (COBI)

Description

Cmax is defined as the maximum observed plasma concentration of COBI.

Time Frame

Pre dose, up to 72 hours post dose (up to Day 4)

Title

Area Under the COBI Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) of COBI

Description

AUC (0-last) is the area under the COBI concentration-time curve from time zero to the time of the last measurable (non-BQL) concentration, calculated by linear-linear trapezoidal summation.

Time Frame

Pre dose, up to 72 hours post dose (up to Day 4)

Title

Area Under the COBI Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of COBI

Description

Time Frame

Pre dose, up to 72 hours post dose (up to Day 4)

Title

Number of Participants With Serious Adverse Events (SAEs)

Description

Time Frame

Up to 7 weeks

Title

Number of Participants with Abnormalities in Physical Examinations

Description

Number of participants with abnormalities in physical examinations (including skin examination, body weight, height and family history related to skin disease) will be reported.

Time Frame

Up to 7 weeks

Title

Number of Participants with Abnormalities in Vital Sign Measurements

Description

Number of participants with abnormalities in vital sign measurements (including temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.

Time Frame

Up to 7 weeks

Title

Number of Participants with Abnormalities in Clinical Laboratory Tests

Description

Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and random urine samples) will be reported.

Time Frame

Up to 7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening (results must be available on Day -1 of Treatment Period 1). If there are any abnormalities (other than those listed in inclusion criterion 12 [for blood pressure]), they must be considered not clinically relevant and 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 (results must be available on Day -1 of Treatment Period 1). 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. This determination must be recorded in the participant's source documents and initialed by the investigator All women must have a negative highly sensitive serum test (beta-human chorionic gonadotropin [beta-hCG]) 4 days or less before dosing of the first treatment period A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention Must sign an informed consent form (ICF) indicating that the participant understands the purpose and procedures required for the study and is willing to participate in the study A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 90 days after last dose Exclusion Criteria: History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) Clinically significant abnormalities during physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site as deemed appropriate by the investigator Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillin's, or drug allergy diagnosed in previous studies with experimental drugs With a clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria Taken any disallowed therapies, concomitant therapy before the planned first dose of study intervention Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

SGS Belgium NV

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

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