Study Completed

Clinical pharmacology

Bayer Identifier:

17116

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000764-17

EU CT Number:

Not Available

Interaction study with mefenamic acid in healthy male subjects

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years

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

Trial Dates

August 2014 - January 2015

Phase

Phase 1

Could I Receive a placebo

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Berlin, 13353, Germany

Primary Outcome

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Vericiguat in Plasma
Time Frame:
0 hours (h) (pre-dose) to 72 h post-dose
Maximum Observed Drug Concentration (Cmax) of Vericiguat in Plasma
Time Frame:
0 h (pre-dose) to 72 h post-dose

Secondary Outcome

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time Frame:
From start of study drug administration until last follow-up visit (approximately 8 weeks)

Trial design

Interaction study to investigate the influence of a starting dose of 500 mg followed by multiple doses of 250 mg mefenamic acid every 6 hours on pharmacokinetics as well as safety and tolerability of a single dose of 2.5 mg vericiguat in comparison to a single dose of 2.5 mg vericiguat alone in healthy male subjects in a randomized, non-blinded, non-placebo-controlled, two-fold cross-over design

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Basic Science

Allocation

Randomized

Blinding

N/A

Assignment

N/A

Trial Arms