Trial Condition(s):

Clinical Pharmacology

Interaction study with mefenamic acid in healthy male subjects

Bayer Identifier:

17116

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000764-17

Study Completed

Trial Purpose

The primary objective of this study was to investigate the influence of a starting dose of 500 mg followed by multiple doses of 250 mg mefenamic acid every 6 hours on the PK of 2.5 mg vericiguat given as a single oral dose in comparison to 2.5 mg vericiguat given alone.

The secondary objective of this study was to assess the influence of a starting dose of 500 mg followed by multiple doses of 250 mg mefenamic acid every 6 hours on the safety and tolerability of 2.5 mg vericiguat given as a single oral dose in comparison to 2.5 mg vericiguat given alone.

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

Trial Summary

Enrollment Goal
16
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

Berlin, Germany, 13353

Status
Completed
 

Trial Design