check_circleStudy Completed

Heart failure

Bayer Identifier:

19699

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2018-003651-38

EU CT Number:

Not Available
Relative bioavailability and food effect study of two new 15 mg vericiguat formulations

Trial purpose

The primary objectives of the pilot part were to
• investigate the safety and tolerability of a single dose of 15 mg vericiguat administered as tablets (loose combination of 10 mg+5 mg IR tablets) under fed conditions.

The primary objectives of the main part were to
• investigate the pharmacokinetics (PK) of vericiguat after oral administration of a single dose of 15 mg of two different formulations compared to a loose combination of 10 mg+5 mg IR tablets under fed conditions,
• investigate the PK of vericiguat after oral administration of a single dose of 15 mg of two different formulations under fed and fasted conditions.

The secondary objectives of the main part were
• safety and tolerability of vericiguat.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male subjects aged 18 to 45 years (inclusive) and with a body mass index above or equal to 18.5 kg/m² and below or equal to 29.9 kg/m² at the first screening visit.

  • - Incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs were not normal.
    - Known hypersensitivity to the study drugs (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 the first 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 the first study drug.
    - Medical disorder that was considered to impair 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), for composition of the American breakfast.

Trial summary

Enrollment Goal
36
Trial Dates
February 2019 - April 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Vericiguat (BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mannheim, 68167, Germany

Primary Outcome

  • For pilot part: Number of subjects with treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    From first application of study intervention up to 30 days after end of treatment with study intervention
  • For main part: Area under the concentration versus time curve from zero to infinity (AUC) after single dose of vericiguat
    date_rangeTime Frame:
    From pre-dose until 72 h after dosing
  • For main part: Maximum observed drug concentration (Cmax) in measured matrix after single dose administration of vericiguat
    date_rangeTime Frame:
    From pre-dose until 72 h after dosing

Secondary Outcome

  • For main part: Number of subjects with treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    From first application of study intervention up to 30 days after end of treatment with study intervention

Trial design

Pivotal relative bioavailability study to investigate the pharmacokinetics, food effect (high fat, high calorie meal/ fasted), safety and tolerability of single oral doses of vericiguat given as 15 mg round high drug load tablet, 15 mg oblong low drug load tablet in comparison to the loose combination of 10 mg and 5 mg immediate release (IR) tablets in healthy male participants in a randomized, open-label, 5-fold crossover design (main part), preceded by a pilot part to investigate safety, tolerability and pharmacokinetics of 15 mg vericiguat (given as loose combination of 10 mg and 5 mg IR tablets) under fed conditions in healthy male participants in an open-label, non-controlled design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
N/A
Trial Arms
2