Trial Condition(s):
Clinical Pharmacology
Vericiguat absolute bioavailability using microdosing technology
Bayer Identifier:
17114
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of this study was to evaluate the absolute bioavailability of an oral dose of 10 mg vericiguat (BAY 1021189) given as two 5 mg immediate release (IR) tablets following a high-fat, high-calorie meal in comparison to a 14C-labeled micro-dose of vericiguat (20 microgram) administered as a 30-min intravenous (i.v.) infusion, 4 h after oral tablet dosing.
The secondary objectives were to further characterize the PK of vericiguat and its metabolite M1 (BAY 1222707), and to investigate the safety and tolerability of vericiguat.
Inclusion Criteria
- Healthy male. - Age: 18 to 55 years (inclusive) at the first screening examination/visit. - Race: white (i.e. Caucasian). - Body mass index (BMI): ≥18.0 and ≤30.0 kg/m2.
Exclusion Criteria
- Incompletely cured pre existing diseases for which it can be assumed that they may alter the absorption, distribution, metabolism, elimination and effects of the study drugs. - Known GI disorders (e.g. stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis). - Medical disorder that would impair the subject’s ability to complete the study in the opinion of the investigator. - History of coronary artery disease. - Symptomatic postural hypotension. - History of asthma bronchiale or other airway disease. - History or suspicion of drug and/or alcohol dependencies. - Myasthenia gravis. - History of apnea after drug intake beyond scheduled anesthesia.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site GRONINGEN, Netherlands, 9728 NZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single-center, open-label study in healthy male subjects to evaluate the absolute bioavailability of a 10 mg oral dose of vericiguat (BAY 1021189) (as IR tablets following a high-fat, high-calorie meal) in comparison to an intravenous, 14C-labeled micro-dose (20 microgram) of vericiguat
Trial Type:
Interventional
Intervention Type:
N/A
Trial Purpose:
Basic Science
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity After Single Dose Divided by Dose (AUC/D) of Oral Vericiguat and 14C-labeled Vericiguat in PlasmaTimeframe: Vericiguat: Pre-dose (0 hour) to 192 hours post-dose; 14C-labeled vericiguat: Pre-dose (4 hours) to 192 hours post-dose
- Maximum Observed Drug Concentration After Single Dose Administration Divided by Dose (Cmax/D) of Oral Vericiguat and 14C-labeled Vericiguat in PlasmaTimeframe: Vericiguat: Pre-dose (0 hour) to 192 hours post-dose; 14C-labeled vericiguat: Pre-dose (4 hours) to 192 hours post-dose
- Absolute Bioavailability of VericiguatTimeframe: Vericiguat: Pre-dose (0 hour) to 192 hours post-dose; 14C-labeled vericiguat: Pre-dose (4 hours) to 192 hours post-dose
Additional Information
Not Available
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