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OpenTrials
Completed

NCT Number: NCT02159313

Relative Bioavailability Study

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riociguat(Adempas,BAY63-2521)

Drug

Single dose of a whole 2.5 mg riociguat tablet

Primary outcomes

  1. Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)

    Time frame: Multiple time points up to day 3

  2. Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)

    Time frame: Multiple time ponits up to day 3

Secondary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 9, 2014
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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