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Relative Bioavailability and Food Effect Study

NCT ID: NCT01489488

Last Updated: 2015-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

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Primary objective: To determine oral bioavailability of the liquid formulation intended for pediatric use and potential food effects in healthy adults.

Secondary objective: To evaluate safety and tolerability measured by physical examination findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events (AEs).

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Detailed Description

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Clinical pharmacology

Conditions

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Pharmacology, Clinical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

Single oral dose of 2.4 milligram (mg) riociguat (BAY63-2521) as pediatric high-concentration suspension (0.15 mg per milliliter \[mg/mL\], i.e. 16 mL) under fasting conditions

Arm 2

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

Single oral dose of 2.4 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 16 mL) under fed conditions

Arm 3

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

Single oral dose of 0.3 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 2 mL) under fasting conditions

Arm 4

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

Single oral dose of 0.15 mg riociguat as pediatric low-concentration suspension (0.03 mg/mL, i.e. 5 mL) under fasting conditions

Arm 5

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

Single oral dose of riociguat immediate release (IR) tablet 1 mg under fasting conditions

Interventions

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Riociguat (BAY63-2521)

Single oral dose of 2.4 milligram (mg) riociguat (BAY63-2521) as pediatric high-concentration suspension (0.15 mg per milliliter \[mg/mL\], i.e. 16 mL) under fasting conditions

Intervention Type DRUG

Riociguat (BAY63-2521)

Single oral dose of 2.4 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 16 mL) under fed conditions

Intervention Type DRUG

Riociguat (BAY63-2521)

Single oral dose of 0.3 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 2 mL) under fasting conditions

Intervention Type DRUG

Riociguat (BAY63-2521)

Single oral dose of 0.15 mg riociguat as pediatric low-concentration suspension (0.03 mg/mL, i.e. 5 mL) under fasting conditions

Intervention Type DRUG

Riociguat (BAY63-2521)

Single oral dose of riociguat immediate release (IR) tablet 1 mg under fasting conditions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female volunteers
* Age 18-45 years
* Body mass index (BMI) 18.0-29.9 kg/m²
* Systolic blood pressure (SBP) 110-145 mmHg
* No drugs 2 weeks before treatment
* Nonsmokers for at least 12 weeks

Exclusion Criteria

* Incompletely cured 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
* Medical disorder that would impair the subject's ability to complete the study in the opinion of the Investigator
* Known hypersensitivity to the study drugs (active substance or excipients of the preparations)
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Regular use of medicines
* Regular use of therapeutic or recreational drugs
* Use of any medication within the 2 weeks preceding the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Related Links

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http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

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2011-001893-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14986

Identifier Type: -

Identifier Source: org_study_id

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