Study Completed

Clinical pharmacology

Bayer Identifier:

17743

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2015-004997-14

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Male

Age

40 - 60 Years

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

Trial Dates

February 2016 - July 2016

Phase

Phase 1

Could I Receive a placebo

Yes

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Mönchengladbach, 41061, Germany

Primary Outcome

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame:
From start of study treatment until 30 days after last administration of the study medication

Secondary Outcome

Maximum Decrease in Seated Systolic Blood Pressure (SBP) Value From Reference Value on Profile Day 0, 12, 13, 14 and 15
Time Frame:
Profile Day 0, 12, 13, 14 and 15
Maximum Decrease in Seated Diastolic Blood Pressure (DBP) Value From Reference Value on Profile Day 0, 12, 13, 14 and 15
Time Frame:
Profile Day 0, 12, 13, 14 and 15
Maximum Increase in Seated Heart Rate (HR) Value From Reference Value on Profile Day 0, 12, 13, 14 and 15
Time Frame:
Profile Day 0, 12, 13, 14 and 15
Mean Change of Seated Systolic Blood Pressure (SBP) Value From Reference Value on Profile Day 0, 12, 13, 14 and 15
Time Frame:
Profile Day 0, 12, 13, 14 and 15
Mean Change of Seated Diastolic Blood Pressure (DBP) Value From Reference Value on Profile Day 0, 12, 13, 14 and 15
Time Frame:
Profile Day 0, 12, 13, 14 and 15
Mean Change of Seated Heart Rate (HR) Value From Reference Value on Profile Day 0, 12, 13, 14 and 15
Time Frame:
Profile Day 0, 12, 13, 14 and 15

Trial design

A randomized, placebo-controlled, single-blind, group-comparison interaction study to investigate the influence of single oral doses of 25 mg, 50 mg and 100 mg sildenafil on top of 10 mg vericiguat or placebo tablets given over 16 days at steady state on safety, tolerability, pharmacodynamic effect and pharmacokinetics in healthy male subjects

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

N/A

Assignment

N/A

Trial Arms