To determine oral bioavailability of the oral liquid formulation and potential food effects.

• Register: EUCTR
• Last refreshed on: 5 August 2013
• Main ID: EUCTR2011-001893-24-DE
• Date of registration: 21/09/2011
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: To determine oral bioavailability of the oral liquid formulation and potential food effects.
• Scientific title: Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg tablet of riociguat to characterize its pharmacokinetic properties in healthy male and female adult subjects in a randomized, open label, 5 fold crossover design
• Date of first enrolment: 13/10/2011
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001893-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
Healthy male or female volunteers, age 18-45 years, BMI 18.0-29.9 kg/m², SBP 110-145 mmHg, no drugs 2 weeks before treatment, non-smokers for at least 12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN)
MedDRA version: 14.0 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0 Level: LLT Classification code 10053592 Term: Newborn persistent pulmonary hypertension System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Product Name: BAY 63-2521 0.3 %
Product Code: BAY 63-2521
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.3-

Product Name: BAY 63-2521 0.06 %
Product Code: BAY 63-2521
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.06-

Product Name: BAY 63-2521 IR tablets 1 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Primary Outcome(s)

Primary end point(s):

Main Objective: The primary objective of the study is to determine oral bioavailability of the liquid formulation intended for paediatric use and potential food effects in healthy adults.

Secondary Objective: Secondary objectives are safty and tolerability measured by the parameters in section 7.4.3. and adverse events.

Secondary ID(s)

Bay63-2521/14986

Source(s) of Monetary Support

Bayer HealthCare AG