Relative Bioavailability and Food Effect Study

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacology, Clinical

Treatments: Drug: Riociguat (BAY63-2521)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01489488

2011-001893-24 (EudraCT Number)

14986

Details and patient eligibility

About

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).

Full description

Clinical pharmacology

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 5 patient groups

Arm 1

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Arm 2

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Arm 3

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Arm 4

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Arm 5

Experimental group

Treatment:

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)

Drug: Riociguat (BAY63-2521)