HealthyPhase 1NCT05378906
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
A Phase 1 study testing DRV/COBI FDC, COBI and DRV in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DRV/COBI FDC, COBI and DRV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Jun 2022to 28 Sep 2022
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- DRV/COBI FDC, COBI, DRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRV/COBI FDCDrug
Also called TMC114/JNJ-48763364
Participants will receive a single oral dose of DRV/COBI FDC tablet dispersed in water as per assigned treatment sequence.
COBIDrug
Also called JNJ-48763364
Participants will receive a single oral dose of COBI tablet as per assigned treatment sequence.
DRVDrug
Also called TMC114
Participants will receive single oral dose of DRV suspension as per the assigned treatment sequence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: DRV/COBI FDC; Drug: COBI; Drug: DRV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV)
Cmax is defined as the maximum observed plasma concentration of DRV.
Measured: 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.
Measured: 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).
Measured: Pre dose, up to 72 hours post dose (up to Day 4)
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax) of Cobicistat (COBI)
Cmax is defined as the maximum observed plasma concentration of COBI.
Measured: 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
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.
Measured: 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
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.
Measured: Pre dose, up to 72 hours post dose (up to Day 4)
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
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.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start7 Jun 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378906
- Sponsor's protocol ID
- CR109173
- Other IDs
- 2021-003955-40, TMC114FD1HTX1004
- Status last verified
- Oct 2022
- First submitted
- 13 May 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05378906
- Acronym / sponsor ID
- CR109173
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 18 May 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: DRV/COBI FDC, Drug: COBI, Drug: DRVParticipants 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. |
| Treatment Sequence BA | Experimental | Drug: DRV/COBI FDC, Drug: COBI, Drug: DRVParticipants 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| DRV/COBI FDCAlso: TMC114/JNJ-48763364Participants will receive a single oral dose of DRV/COBI FDC tablet dispersed in water as per assigned treatment sequence. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| COBIAlso: JNJ-48763364Participants will receive a single oral dose of COBI tablet as per assigned treatment sequence. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| DRVAlso: TMC114Participants will receive single oral dose of DRV suspension as per the assigned treatment sequence. | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Darunavir (DRV)
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
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
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
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
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
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).
7 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Cobicistat (COBI)
Time frame: 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
Time frame: 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
Time frame: Pre dose, up to 72 hours post dose (up to Day 4)
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 7 weeks
Number of Participants with Abnormalities in Physical Examinations
Time frame: Up to 7 weeks
Number of Participants with Abnormalities in Vital Sign Measurements
Time frame: Up to 7 weeks
Number of Participants with Abnormalities in Clinical Laboratory Tests
Time frame: Up to 7 weeks
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 26 Oct 2022.
- Individual participant dataSharing planned: 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
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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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, 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 DRV/COBI FDC, COBI and DRV in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 6 inclusion and 7 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 26 Oct 2022. 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 Belgium. 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) of Darunavir (DRV) (time frame: Pre dose, up to 72 hours post dose (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?
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 26 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.