Study 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

Inclusion Criteria
- Healthy male white subjects, 18 to 45 years of age (inclusive), BMI ≥18.0 and ≤29.9 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 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

Trial Dates

June 2016 - November 2016

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) After Single Dose of Vericiguat in Plasma (Dose Proportionality)
Time 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)
Time 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)
Time 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)
Time 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