check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

17114

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2015-001568-20

EU CT Number:

Not Available
Vericiguat absolute bioavailability using microdosing technology

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • - 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.

  • - 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
10
Trial Dates
October 2015 - July 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
GRONINGEN, 9728 NZ, Netherlands

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 Plasma
    date_rangeTime Frame:
    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 Plasma
    date_rangeTime Frame:
    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 Vericiguat
    date_rangeTime Frame:
    Vericiguat: Pre-dose (0 hour) to 192 hours post-dose; 14C-labeled vericiguat: Pre-dose (4 hours) to 192 hours post-dose

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
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
1