Trial Condition(s):

Clinical Pharmacology

Interaction study of vericiguat with digoxin in healthy male subjects

Bayer Identifier:

15841

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-004733-75

Study Completed

Trial Purpose

The primary objective of this study was to investigate the influence of a concomitant intake of multiple doses of 10 mg vericiguat administered once-daily (od) for 9 days on the steady state PK of digoxin (0.375 mg od).

The secondary objective of this study was to assess the safety and tolerability of the combined administration of both drugs and to determine the influence of multiple doses of digoxin (0.375 mg od) on the PK of a single dose of 10 mg vericiguat.

Inclusion Criteria
- Healthy male subject
- Age: 18 to 55 years (inclusive) at the first screening examination / visit
- Race: White
- Body mass index: above/equal 18 and below/equal 30 kg/m²
Exclusion Criteria
-  Incompletely cured pre-existing diseases for which it was possible to assume that the absorption, distribution, metabolism, elimination and effects of the study drugs would not be normal
- Known hypersensitivity to the study drug (active substances or excipients of the preparations) or digoxin
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Known gastrointestinal (GI) disorders (eg stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (eg Crohn’s disease, ulcerative colitis)
- Subjects with thyroid disorders
- Subjects with Gilbert’s syndrome (associated with the UGT1A1 promoter genotype)
- Hepatic impairment, past or present on day of screening
- Renal impairment, past or present at day of screening
- Diagnosed malignancy, past or present at day of screening

Trial Summary

Enrollment Goal
25
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mannheim, Germany, 68167

Status
Completed
 

Trial Design