check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

15815

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-003982-13

EU CT Number:

Not Available
Interaction study of vericiguat with midazolam in healthy male subjects

Trial purpose

The primary objective was to investigate the influence of multiple doses of 10 mg vericiguat once daily given as a single oral dose on the pharmacokinetics of a single oral dose of 7.5 mg midazolam.

The secondary objective was to assess the influence of multiple doses of 10 mg vericiguat once daily given as a single oral dose on the safety and tolerability of a single oral dose of midazolam.

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 18.0 and below / equal 30.0 kg/m2

  • - Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal.
    - Known gastrointestinal (GI) disorders (e.g. stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)
    - Medical disorder that would have impaired the subject’s ability to complete the study in the opinion of the investigator.
    - History of coronary artery disease (CAD)
    - Symptomatic postural hypotension (e.g. dizziness, lightheadedness).
    - History of bronchial asthma or other airway disease.
    - History of dependencies.
    - Myasthenia gravis.
    - History of apnea after drug intake beyond scheduled anesthesia.
    - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) or to midazolam.

Trial summary

Enrollment Goal
32
Trial Dates
February 2015 - October 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mönchengladbach, 41061, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Midazolam in Plasma
    date_rangeTime Frame:
    0 hour (h) pre-dose to 48 h post-dose
  • Maximum Observed Concentration (Cmax) of Midazolam in Plasma
    date_rangeTime Frame:
    0 hour (h) pre-dose to 48 h post-dose

Trial design

Single-center, randomized, non-blinded, non-placebo-controlled, twofold crossover study to investigate the influence of multiple doses of 10 mg OD vericiguat on pharmacokinetics, safety and tolerability of a single oral dose of 7.5 mg midazolam in comparison to a single dose of 7.5 mg midazolam alone in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2