Trial Condition(s):

Clinical Pharmacology

Interaction study with the PDE-5 inhibitor sildenafil in healthy male subjects

Bayer Identifier:

17743

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2015-004997-14

Study Completed

Trial Purpose

The primary objective of this study was
•    to investigate the safety and tolerability of 10 mg vericiguat administered once daily for 16 days and of single doses of 25 mg, 50 mg, and 100 mg sildenafil co-administered with steady-state vericiguat.

The secondary objectives of this study were
•    to assess the pharmacodynamic interaction between single doses of 25 mg, 50 mg, and 100 mg sildenafil and steady-state vericiguat.
•    to investigate the pharmacokinetic (PK) interaction potential between sildenafil and steady-state vericiguat.

Inclusion Criteria
- Age: 40 to 60 years (inclusive) at the first screening examination
- Race: white (i.e., Caucasian)
- Body mass index (BMI): ≥18.0 and ≤29.9 kg/m2
Exclusion Criteria
-  Incompletely cured pre-existing diseases for which it could be assumed that they may have altered the absorption, distribution, metabolism, elimination and effects of the study drugs
- Medical disorder that would have impaired the subject’s ability to complete the study in the opinion of the investigator
- Known gastrointestinal (GI) disorders (e.g., stomach ulcers, duodenal ulcers, gastrointestinal bleeding) or inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
- Symptomatic postural hypotension (e.g., dizziness, lightheadedness)
- History of hypotension (anamnestic blood pressure <90/50 mmHg)
- History of bronchial asthma or other airway disease
- History of priapism
- History or suspicion of drug and/or alcohol dependencies
- History of apnea after drug intake beyond scheduled anesthesia

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design