CompletedNCT04208061Updated Feb 3, 2025

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

A Phase 1 interventional study of Dabigatran Etexilate and DRV/COBI in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Other

From the registry’s dates

Primary completion was Mar 2021, 5 years 6 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 28
Allocation: Non-randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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 participants.

Conditions studied

Healthy

In context

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 28 participants (actual)

Study arms

Experimental
Panel 1: Dabigatran etexilate +DRV/COBI
Participants 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).
Drug: Dabigatran Etexilate · Drug: DRV/COBI
Experimental
Panel 2: Dabigatran etexilate +DRV+rtv
Participants 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).
Drug: Dabigatran Etexilate · Drug: Ritonavir · Drug: Darunavir

Interventions

DrugDabigatran Etexilate
Participants will receive single dose of dabigatran etexilate orally.
DrugDRV/COBI
Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).
Also known as: REZOLSTA
DrugRitonavir
Participants will receive ritonavir orally.
DrugDarunavir
Participants will receive Darunavir orally.

What researchers measure

Primary outcomes

Maximum Observed Analyte Concentration (Cmax) of Dabigatran Etexilate (Free and Total)
Cmax is the maximum observed analyte concentration.
Time frame: Up to Day 18
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.
Time frame: Up to Day 18
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.
Time frame: Up to Day 18

Secondary outcomes

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.
Time frame: From signing of the ICF up to end of study (up to 8 weeks)

Study locations

1 site

Clinical Pharmacology Unit
Merksem, 2170, Belgium

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04208061
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Dec 23, 2019
Start date: Dec 18, 2019
Primary completion: Mar 25, 2021
Completion: Apr 1, 2021
Last update: Feb 3, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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