check_circleStudy 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
  • - 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

  • - 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
August 2014 - January 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

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

Secondary Outcome

  • Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
    date_rangeTime 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
2