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Anticoagulant

Pharmacokinetic study in healthy volunteers for Healthy Subjects

Phase 1

Waitlist Available

Led By Jomy M George, Pharm.D.

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 7 and 13 at the following times: arm a (rivaroxaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. arm b (apixaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Awards & highlights

Study Summary

This trial is testing whether the anti-HIV drugs darunavir (DRV) and cobicistat (COBI) increase blood levels of the blood thinners rivaroxaban or apixaban.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 7 and 13 at the following times: arm a (rivaroxaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. arm b (apixaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 7 and 13 at the following times: arm a (rivaroxaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. arm b (apixaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 7 and 13 at the following times: arm a (rivaroxaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. arm b (apixaban): times 0 (predose), 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent Oral Clearance (CL/F) for Rivaroxaban

Apparent Volume of Distribution (V/F) for Rivaroxaban

Area Under the Concentration Versus Time Curve (AUC0-24hr) for Rivaroxaban

+5 more

Secondary outcome measures

(1) Area under the effect curve for factor Xa, aPTT and PT from 0 to 24 hours (AUEC0-24), and the maximum effect ratio over baseline (ERmax)

(2) AEs and abnormal laboratory values, as graded according to the DAIDS AE table and Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials AE table (total bilirubin only).

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pharmacokinetic study in healthy volunteersExperimental Treatment3 Interventions

Healthy participants received a single dose of rivaroxaban 10 mg orally on day 1 (phase 1) followed by cobicistat 150 mg once daily from days 2 - 7 and a single dose of rivaroxaban 10 mg on day 7 (phase 2). Participants received darunavir /cobicistat 800/150 mg once daily from days 8 - 13 followed by a single dose of rivaroxaban 10mg on day 13 (phase 3). Serial blood sampling was done on days 1, 7, and 13.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Darunavir/Cobicistat

2017

Completed Phase 4

~420

Rivaroxaban

2015

Completed Phase 4

~157350

Cobicistat

2014

Completed Phase 2

~640

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor

383 Previous Clinical Trials

881,186 Total Patients Enrolled

Jomy M George, Pharm.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

Colleen M Hadigan, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

9 Previous Clinical Trials

1,584 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I possess the necessary criteria to participate in this experiment?

"To qualify for this clinical trial, participants must be hale and hearty individuals aged between 18 to 65 years old. This research is looking for 40 volunteer patients in total."

Answered by AI

Does the age requirement for this trial extend beyond sixty years of age?

"This medical trial permits patients aged 18-65 to participate. Conversely, there are 55 separate trials specially tailored for minors and 466 studies targeting seniors in the same field."

Answered by AI

Could you elucidate the potential risks of administering Rivaroxaban?

"As Phase 1 trials typically lack sufficient data to support safety and efficacy, Xarelto (Rivaroxaban) was awarded a score of 1."

Answered by AI

Are physicians actively enrolling participants in this trial?

"Yes, clinicaltrials.gov has records of this trial actively recruiting patients. The research was posted on June 4th 2019 and last amended on September 29th 2022; it demands 40 participants between 1 site."

Answered by AI

How many research participants are actively involved in this experiment?

"Affirmative. The details on clinicaltrials.gov indicate that the trial, which was initially announced on June 4th 2019, is actively recruiting participants. A total of 40 patients are needed from a single medical facility."

Answered by AI

What benefits are researchers seeking to establish through this clinical investigation?

"The primary aims of this clinical trial, which will be assessed on Days 1, 7 and 13 through the collection of data at Arm A (Rivaroxaban): 0(pre-dose),1,2,3,4.6.8.10 & 24 hours post dose; Arm B (Apixaban) 0(pre-dose).1,2.3,.4,.6., 8 10 12 & 24 hours post dose include assessing Plasma area under the curve during a dosing window from 0 to infinity (AUC0 -inf.), maximum total plasma concentration (Cmax), time to reach maximal plasma concentration level"

Answered by AI

In what medical contexts is Rivaroxaban (Xarelto) commonly prescribed?

"Xarelto (Rivaroxaban) is frequently administered for prophylaxis of systemic embolism, alongside being used to lessen cardiovascular mortality, recurrent prevention of deep vein thrombosis and HIV-1 infection."

Answered by AI

Recent research and studies

Antimicrobial Agents and ChemotherapyJournal

Differential Influence of the Antiretroviral Pharmacokinetic Enhancers Ritonavir and Cobicistat on Intestinal P-glycoprotein Transport and the Pharmacokinetic/pharmacodynamic Disposition of Dabigatran

Kumar, Parag, Lori A. Gordon, Kristina M. Brooks, Jomy M. George, Anela Kellogg, Maryellen McManus, Raul M. Alfaro, et al.. 2017. “Differential Influence of the Antiretroviral Pharmacokinetic Enhancers Ritonavir and Cobicistat on Intestinal P-glycoprotein Transport and the Pharmacokinetic/pharmacodynamic Disposition of Dabigatran”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.01201-17.

British Journal of Clinical PharmacologyJournal

Co-administration of Rivaroxaban with Drugs That Share Its Elimination Pathways: Pharmacokinetic Effects in Healthy Subjects

Mueck, Wolfgang, Dagmar Kubitza, and Michael Becka. 2013. “Co-administration of Rivaroxaban with Drugs That Share Its Elimination Pathways: Pharmacokinetic Effects in Healthy Subjects”. British Journal of Clinical Pharmacology. Wiley. doi:10.1111/bcp.12075.

British Journal of Clinical PharmacologyJournal

Safety, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of Apixaban, a Factor <scp>x</scp> a Inhibitor, in Healthy Subjects

Frost, Charles, Sunil Nepal, Jessie Wang, Alan Schuster, Wonkyung Byon, Rebecca A. Boyd, Zhigang Yu, et al.. 2013. “Safety, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of Apixaban, a Factor x a Inhibitor, in Healthy Subjects”. British Journal of Clinical Pharmacology. Wiley. doi:10.1111/bcp.12106.

Antimicrobial Agents and ChemotherapyJournal