Trial Condition(s):

Clinical Pharmacology

Interaction study vericiguat with Entresto® (sacubitril/valsartan) in healthy male subjects

Bayer Identifier:

17745

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2015-004809-16

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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)
Exclusion Criteria
-  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).

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design