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:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)Timeframe: 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 15Timeframe: 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 15Timeframe: 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 15Timeframe: 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 15Timeframe: 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 15Timeframe: 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 15Timeframe: Profile Day 0, 12, 13, 14 and 15
Additional Information
Not Available
Copyright © Bayer
Powered by
