check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:
18580
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
2016-000980-18
EU CT Number:
Not Available
Pivotal food effect and dose proportionality study with 2.5 mg, 5 mg and 10 mg vericiguat IR tablets

Trial purpose

The primary objective of this study was to
• investigate the PK dose proportionality of single oral doses of 2.5 mg and 5 mg vericiguat tablet in comparison to 10 mg vericiguat tablet in fed condition
• investigate the effect of a high fat, high calorie meal on the PK of vericiguat after a single oral dose of the 10 mg tablet in comparison to the 10 mg tablet in fasted state

The secondary objectives of this study were to assess the
• safety and tolerability of vericiguat

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male white subjects, 18 to 45 years of age (inclusive), BMI ≥18.0 and ≤29.9 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 was not normal
    - Known hypersensitivity to the study drug (active substances or excipients of the preparations)
    - Known severe allergies, non-allergic drug reactions, or multiple drug allergies
    - Febrile illness within 1 week prior to study drug administration
    - History of postural syncopes
    - A history of relevant diseases of vital organs, of the central nervous system or other organs
    - Relevant diseases within the last 4 weeks prior to study drug administration
    - Medical disorder that would have impaired the subject’s ability to complete the study in the opinion of the investigator.
    - Known hypersensitivity to components of the American breakfast (high fat, high calorie breakfast)

Trial summary

Enrollment Goal
30
Trial Dates
June 2016 - November 2016
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) After Single Dose of Vericiguat in Plasma (Dose Proportionality)
    date_rangeTime Frame:
    0 hour (pre-dose) to 72 hours post-dose
  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) After Single Dose of Vericiguat in Plasma (Food Effect)
    date_rangeTime Frame:
    0 hour (pre-dose) to 72 hours post-dose
  • Maximum Observed Concentration (Cmax) of Vericiguat in Measured Matrix After Single Dose Administration (Dose Proportionality)
    date_rangeTime Frame:
    0 hour (pre-dose) to 72 hours post-dose
  • Maximum Observed Concentration (Cmax) of Vericiguat in Measured Matrix After Single Dose Administration (Food Effect)
    date_rangeTime Frame:
    0 hour (pre-dose) to 72 hours post-dose

Trial design

Pivotal food effect and dose proportionality study to investigate pharmacokinetics, safety and tolerability following administration of 2.5 mg, 5 mg and 10 mg vericiguat (BAY 1021189) as IR tablets following a high fat, high calorie meal and 10 mg fasted in 32 healthy male subjects in a randomized, open-label, four-fold cross-over design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
4