Relative Bioavailability Study

NCT02159313 | Completed Phase 1

• 2 other identifiers: 173062013-005166-18
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Biological Availability

Outcome Measures

Primary Outcomes (2)

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

  Multiple time points up to day 3

• Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)

  Multiple time ponits up to day 3

Secondary Outcomes (1)

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

  Up to 12 weeks

Study Arms (4)

BAY63-2521 with Non sparkling water

EXPERIMENTAL

Single dose of a whole 2.5 mg riociguat tablet (fasted) with 240 mL of non-sparkling water at room temperature

Drug: Riociguat(Adempas,BAY63-2521)

BAY63-2521 with applesauce

EXPERIMENTAL

Single dose of a crushed 2.5 mg riociguat tablet suspended in 50 mL applesauce, to be eaten with a spoon (fasted)

Drug: Riociguat(Adempas,BAY63-2521)

BAY63-2521 with water

EXPERIMENTAL

Single dose of a crushed 2.5 mg riociguat tablet suspended in a glass with 25 mL water, to be drunk and flushed twice with 25 mL water in the same glass (fasted)

Drug: Riociguat(Adempas,BAY63-2521)

BAY63-2521 after breakfast

EXPERIMENTAL

Single dose of a whole 2.5 mg riociguat tablet taken within 5 minutes after the last bite of a continental breakfast (fed) with 240 mL of non-sparkling water at room temperature

Drug: Riociguat(Adempas,BAY63-2521)

Interventions

Riociguat(Adempas,BAY63-2521) DRUG

Single dose of a whole 2.5 mg riociguat tablet

BAY63-2521 after breakfast; BAY63-2521 with Non sparkling water; BAY63-2521 with applesauce; BAY63-2521 with water

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 9, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

DE (1)