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

NCT05378906 | Completed Phase 1

• 3 other identifiers: CR1091732021-003955-40TMC114FD1HTX1004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

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

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

• 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.

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

• 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).

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

Secondary Outcomes (7)

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

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

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

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

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

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

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 7 weeks

• Number of Participants with Abnormalities in Physical Examinations

  Up to 7 weeks

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

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.

Drug: DRV/COBI FDC; Drug: COBI; Drug: DRV

Treatment Sequence BA

EXPERIMENTAL

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

Drug: DRV/COBI FDC; Drug: COBI; Drug: DRV

Interventions

DRV/COBI FDC DRUG

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

Also known as: TMC114/JNJ-48763364

Treatment Sequence AB; Treatment Sequence BA

COBI DRUG

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

Also known as: JNJ-48763364

Treatment Sequence AB; Treatment Sequence BA

DRV DRUG

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

Also known as: TMC114

Treatment Sequence AB; Treatment Sequence BA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

SGS Belgium NV

Edegem, 2650, Belgium

Location

MeSH Terms

Interventions

Darunavir

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: June 7, 2022
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)