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HealthyPhase 1NCT04208061

A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants

A Phase 1 study testing Dabigatran Etexilate, DRV/COBI and Ritonavir in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate effect of single and repeated doses of darunavir (DRV) in combination with cobicistat (DRV/COBI) and with ritonavir (DRV+rtv) on the pharmacokinetics of single dose dabigatran etexilate (measured in plasma as free and total dabigatran) when co-administered in healthy… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Dabigatran Etexilate, DRV/COBI and Ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteBelgium
Study dates
18 Dec 2019to 1 Apr 2021
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must have a body mass index (BMI) (weight in kilogram [kg]/height^2 in square meters [m^2] ) between 18.0 and 30.0 kg/m^2 (inclusive) and body weight not less than 50.0 kg
  • Must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study
  • A woman must have a negative highly sensitive serum beta human chorionic gonadotropin (beta hCG) pregnancy test at screening, on Day -1 (only if the test performed at screening was greater than [>] 4 days before dosing), and at the end of the study
  • 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
  • Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug

Who cannot join

  • Clinically significant abnormalities during physical examination, vital signs, or 12 lead - electrocardiogram (ECG) at screening 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
  • With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
  • Has donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
  • Has received an investigational drug or used an investigational medical device within 60 days before the first intake of study drug

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Clinical Pharmacology Unit

    Merksem, 2170

Other trials in Belgium

About this study

Official title: A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects

The purpose of this study is to evaluate effect of single and repeated doses of darunavir (DRV) in combination with cobicistat (DRV/COBI) and with ritonavir (DRV+rtv) on the pharmacokinetics of single dose dabigatran etexilate (measured in plasma as free and total dabigatran) when co-administered in healthy participants.

Conditions
Healthy
Being tested
Dabigatran Etexilate, DRV/COBI, Ritonavir, Darunavir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dabigatran EtexilateDrug

    Participants will receive single dose of dabigatran etexilate orally.

  • DRV/COBIDrug

    Also called REZOLSTA

    Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).

  • RitonavirDrug

    Participants will receive ritonavir orally.

  • DarunavirDrug

    Participants will receive Darunavir orally.

Study groups in NCT04208061
Study groupRoleWhat they receive
Panel 1: Dabigatran etexilate +DRV/COBIExperimentalParticipants will receive Treatment A (single dose of Dabigatran etexilate orally) on Day 1 followed by Treatment B (single dose of Darunavir/ cobicistat [DRV/COBI] as fixed dose combination tablet orally and single dose of dabigatran etexilate) on Day 4 followed by Treatment C ([DRV/COBI] as fixed dose combination tablet orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18).
Receives: Drug: Dabigatran Etexilate; Drug: DRV/COBI
Panel 2: Dabigatran etexilate +DRV+rtvExperimentalParticipants will receive Treatment D (single dose of dabigatran etexilate orally) on Day 1 followed by Treatment E (single doses of Darunavir, and ritonavir [rtv], and single dose of dabigatran etexilate on Day 4), followed by Treatment F (DRV and rtv orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18).
Receives: Drug: Dabigatran Etexilate; Drug: Ritonavir; Drug: Darunavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Analyte Concentration (Cmax) of Dabigatran Etexilate (Free and Total)

    Cmax is the maximum observed analyte concentration.

    Measured: Up to Day 18

  2. Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Dabigatran Etexilate (Free and Total)

    AUC(0-last) is the Area under the curve (AUC) from time 0 to the time of last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.

    Measured: Up to Day 18

  3. Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC0-infinity) of Dabigatran Etexilate (Free and Total)

    AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time.

    Measured: Up to Day 18

Secondary outcomes (1)

  1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: From signing of the ICF up to end of study (up to 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start18 Dec 2019
  3. Primary completion25 Mar 2021
  4. Study completion1 Apr 2021

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04208061
Sponsor's protocol ID
CR108697
Other IDs
2019-003328-19, TMC114FD1HTX1002, 2019
Status last verified
Jan 2025
First submitted
19 Dec 2019
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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

Publications

  • LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

    PubMed 39971605

  • LaRoche JK, Alvarenga R, Collins M, Costelloe T, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored clinical research: an analysis of a phase-1 randomised clinical study and discussion of opportunities to reduce its impact. BMJ Open. 2024 Jan 11;14(1):e077129. doi: 10.1136/bmjopen-2023-077129.

    PubMed 38216192

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dabigatran Etexilate, DRV/COBI and Ritonavir 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 7 inclusion and 5 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 3 Feb 2025. 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 Analyte Concentration (Cmax) of Dabigatran Etexilate (Free and Total) (time frame: Up to Day 18). 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?

On the ClinicalTrials.gov record for NCT04208061, which also lists 2 linked publications.

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 3 Feb 2025.

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