Back to results

A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants

Primary Purpose

Thromboembolic Disorders

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Rivaroxaban (Xarelto, BAY59-7939)

About this trial

This is an interventional basic science trial for Thromboembolic Disorders focused on measuring Thromboembolism

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

The informed consent had to be signed before any study specific tests or procedures were done
Healthy male subjects
Age: 18 to 55 years (inclusive) at the screening examination/visit
Race: White
Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m^2
Ability to understand and follow instructions

Exclusion Criteria:

Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
Known or suspected liver disorders and bile secretion/flow
Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening
Personal or familial history of genetically muscular diseases
Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract- allergic asthma, allergies requiring therapy with corticosteroids, urticaria) or significant non-allergic drug reactions
Known disorders with increased bleeding risk (e.g., periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
Known sensitivity to common causes of bleeding (e.g. nasal)
Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular (AV) block, prolongation of the QRS (QRS interval in ECG) complex over 120 msec or of the QTc-interval over 450 msec at the first screening visit
Presence or history of arrhythmic disturbances; or known congenital QT (QT interval in ECG) prolongation
Systolic blood pressure below 100 or above 140 mmHg
Diastolic blood pressure below 50 or above 90 mmHg
Heart rate below 50 or above 90 beats/ min

Sites / Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment A-B

Treatment B-A

Arm Description

Subjects received a single oral dose of 10 mg rivaroxaban tablet in the fasted state on Day 1 (Treatment A) during intervention period 1; and then a single oral dose of 10 mg rivaroxaban oral suspension in the fasted state on Day 1 (Treatment B) during intervention period 2. A wash-out of at least 7 days was maintained between the treatments.

Subjects received a single oral dose of 10 mg rivaroxaban oral suspension in the fasted state on Day 1 (Treatment B) during intervention period 1; and then a single oral dose of 10 mg rivaroxaban tablet in the fasted state on Day 1 (Treatment A) during intervention period 2. A wash-out of at least 7 days was maintained between the treatments.

Outcomes

Primary Outcome Measures

Area under the concentration versus time curve from zero to infinity (AUC) of rivaroxaban in plasma after single dose

AUC from time zero to the last data point greater than (>) lower limit of quantification (LLOQ) (AUC[0-tlast]) of rivaroxaban in plasma after single dose

Area under the concentration versus time curve from zero to infinity (AUC)

Maximum observed drug concentration (Cmax) of rivaroxaban in plasma after single dose

Secondary Outcome Measures

Number of subjects with treatment-emergent adverse events (TEAEs)

Full Information

NCT ID

NCT04720092

First Posted

January 20, 2021

Last Updated

January 20, 2021

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04720092

Brief Title

A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants

Official Title

Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of 10 mg Granules for Oral Suspension Rivaroxaban Versus 10 mg Tablets Rivaroxaban Under Fasted Condition in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

July 5, 2017 (Actual)

Primary Completion Date

August 28, 2017 (Actual)

Study Completion Date

October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Researchers were looking for another way to treat people with a blood clot in their veins. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it behaves. In this trial, the researchers learned how a new liquid form of rivaroxaban behaved compared to the tablet form in a small number of healthy participants. They also wanted to find out how safe it was. The trial included about 30 white men who were between the ages of 18 and 55. The participants also had a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m^2). BMI is a measurement that uses a person's height and weight to learn how much body fat they have. All the participants in this trial took 10 milliliter of the new form of rivaroxaban (containing 1 milligram [mg] of rivaroxaban per milliliter). Later they also took 10 mg of the current tablet form of rivaroxaban. They took each form 1 time by mouth. This trial was a "crossover" trial. In a crossover trial, all the participants take all of the treatments, but in a different order. In between the 2 treatments, there was a "washout period" of at least 7 days. This was done so that the first treatment could leave each participant's body before they took their next treatment. While taking each treatment, the participants stayed at the trial site for 5 days. During this time, they did not eat food for at least 10 hours before and at least 4 hours after taking each treatment. After taking the last treatment, the participants had a final visit about 7 to 14 days later. During the trial, the doctors took blood and urine samples. They also did physical examinations and checked the participants' heart health using an electrocardiogram (ECG). They asked the participants questions about how they were feeling and if they had any medical problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thromboembolic Disorders

Keywords

Thromboembolism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A-B

Arm Type

Experimental

Arm Description

Arm Title

Treatment B-A

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Description

Granules for oral suspension, 10 mg, oral, single dose

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Description

Tablet, 10 mg, oral, single dose

Primary Outcome Measure Information:

Title

Area under the concentration versus time curve from zero to infinity (AUC) of rivaroxaban in plasma after single dose

Time Frame

Pre-dose up to 72 hours post-dose

Title

AUC from time zero to the last data point greater than (>) lower limit of quantification (LLOQ) (AUC[0-tlast]) of rivaroxaban in plasma after single dose

Description

Area under the concentration versus time curve from zero to infinity (AUC)

Time Frame

Pre-dose up to 72 hours post-dose

Title

Maximum observed drug concentration (Cmax) of rivaroxaban in plasma after single dose

Time Frame

Pre-dose up to 72 hours post-dose

Secondary Outcome Measure Information:

Title

Number of subjects with treatment-emergent adverse events (TEAEs)

Time Frame

From start of study drug administration up to 30 days after last study drug administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The informed consent had to be signed before any study specific tests or procedures were done Healthy male subjects Age: 18 to 55 years (inclusive) at the screening examination/visit Race: White Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m^2 Ability to understand and follow instructions Exclusion Criteria: Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal Known or suspected liver disorders and bile secretion/flow Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening Personal or familial history of genetically muscular diseases Known hypersensitivity to the study drugs (active substances or excipients of the preparations) Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract- allergic asthma, allergies requiring therapy with corticosteroids, urticaria) or significant non-allergic drug reactions Known disorders with increased bleeding risk (e.g., periodontosis, hemorrhoids, acute gastritis, peptic ulcer) Known sensitivity to common causes of bleeding (e.g. nasal) Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular (AV) block, prolongation of the QRS (QRS interval in ECG) complex over 120 msec or of the QTc-interval over 450 msec at the first screening visit Presence or history of arrhythmic disturbances; or known congenital QT (QT interval in ECG) prolongation Systolic blood pressure below 100 or above 140 mmHg Diastolic blood pressure below 50 or above 90 mmHg Heart rate below 50 or above 90 beats/ min

Facility Information:

Facility Name

CRS Clinical-Research-Services Mönchengladbach GmbH

City

Mönchengladbach

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41061

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Links:

URL

https://clinicaltrials.bayer.com/

Description

Click here to find results for studies related to Bayer products

Learn more about this trial

A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants

We'll reach out to this number within 24 hrs