Interaction study with the PDE-5 inhibitor sildenafil in healthy male subjects
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.
- 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
Mönchengladbach, Germany, 41061
E-mail: [email protected]
Phone: Not Available
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