Relative Bioavailability Study

Healthy Volunteers Clinical Trial

Official title:

Relative Bioavailability Study of Riociguat Given Orally as a Crushed 2.5 mg Tablet Suspended in Applesauce, Crushed 2.5 mg Tablet Suspended in Water, and Whole 2.5 mg Tablet After a Continental Breakfast in Comparison to a Whole 2.5 mg Tablet Given in the Fasted State to Characterize the Pharmacokinetic Properties in Healthy Male Adult Subjects in a 4-fold Crossover Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159313
• Other study ID #: 17306
• Secondary ID: 2013-005166-18
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2014
• Last updated: February 16, 2016
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To investigate relative bioavailability of crushed tablets suspended in apple sauce or water

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male subject

• Age: 18 to 45 years (inclusive) at the first screening examination

• Ethnicity: white

• Body mass index (BMI): >18 and <29.9 kg/m2

Exclusion Criteria:

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, or effects of the study drug will not be normal

• History of coronary artery disease

• Symptomatic postural hypotension (e.g. dizziness, lightheadedness)

• History of bronchial asthma or any other airway disease

• Smoking (former smokers who have stopped smoking at least 3 months before the first study drug administration may be included)

• Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 ms or of the QTc interval (QT interval corrected for heart rate) over 450 ms

• Systolic blood pressure below 100 or above 145 mmHg

• Diastolic blood pressure below 50 or above 95 mmHg

• Heart rate below 45 or above 95 beats per minute

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Riociguat(Adempas,BAY63-2521)
Single dose of a whole 2.5 mg riociguat tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)		Multiple time points up to day 3	No
Primary	Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)		Multiple time ponits up to day 3	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 12 weeks	Yes

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