Trial Condition(s):
Clinical Pharmacology
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
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
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) After Single Dose of Vericiguat in Plasma (Dose Proportionality)Timeframe: 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)Timeframe: 0 hour (pre-dose) to 72 hours post-dose
- Maximum Observed Concentration (Cmax) of Vericiguat in Measured Matrix After Single Dose Administration (Dose Proportionality)Timeframe: 0 hour (pre-dose) to 72 hours post-dose
- Maximum Observed Concentration (Cmax) of Vericiguat in Measured Matrix After Single Dose Administration (Food Effect)Timeframe: 0 hour (pre-dose) to 72 hours post-dose
Additional Information
Not Available
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