check_circleStudy 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
  • - 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

  • - 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
February 2016 - July 2016
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mönchengladbach, 41061, Germany

Primary Outcome

  • Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
    date_rangeTime 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
2