Interaction study vericiguat with Entresto® (sacubitril/valsartan) in healthy male subjects
The primary objective of this study was to
- investigate safety and tolerability of co administration of 2.5 mg vericiguat once daily (od) and sacubitril and valsartan 97/103 mg twice daily (bid) over 14 days at steady state.
The secondary objectives of this study were to
- assess pharmacodynamic interaction of co-administration of 2.5 mg vericiguat (od) and sacubitril and valsartan 97/103 mg (bid) over 14 days at steady state.
- investigate the pharmacokinetic interaction potential of co-administration of 2.5 mg vericiguat (od) and sacubitril and valsartan 97/103 mg (bid) over 14 days at steady state.
- Healthy male subjects with a body mass index above/equal 18.0 and below/equal 29.9 kg / m2 and age from 40 to 60 years (inclusive)
- Incompletely cured pre-existing diseases which could have altered the absorption, distribution, metabolism, elimination and effects of the study drugs. - Medical disorder with potential to impair 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). - History of symptomatic postural hypotension (e.g. dizziness, lightheadedness), postural symptoms or syncope. - History of hypotension (anamnestic blood pressure <90/50 mmHg). - History or suspicion of drug and/or alcohol dependencies. - Known hypersensitivity to the study drug (active substance or excipients of the preparations). - Lactose intolerance. - Known severe allergies, non-allergic drug reactions or multiple drug allergies (i.e. angioedema).
Mönchengladbach, Germany, 41061
E-mail: [email protected]
Phone: Not Available
A randomized, single-blind, placebo-controlled interaction study to investigate the influence of co-administration of 2.5 mg vericiguat once daily and Entresto® 97/103 mg (sacubitril/ valsartan) twice daily at steady state on the safety, tolerability, pharmacodynamics and pharmacokinetics in healthy male subjects