Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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5 August 2013 |
Main ID: |
EUCTR2011-001893-24-DE |
Date of registration:
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21/09/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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To determine oral bioavailability of the oral liquid formulation and potential food effects.
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Scientific title:
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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:
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13/10/2011 |
Target sample size:
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30 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001893-24 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Bayer Clinical Trials Contact
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Address:
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CTP Team / Ref: "EU CTR"
D-13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.com |
Affiliation:
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Bayer HealthCare AG |
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Name:
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Bayer Clinical Trials Contact
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Address:
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CTP Team / Ref: "EU CTR"
D-13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contact@bayerhealthcare.com |
Affiliation:
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Bayer HealthCare AG |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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-
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Primary Outcome(s)
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Primary end point(s):
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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.
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Secondary Objective: Secondary objectives are safty and tolerability measured by the parameters in section 7.4.3. and adverse events.
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Secondary ID(s)
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Bay63-2521/14986
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Source(s) of Monetary Support
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Bayer HealthCare AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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