Trial Condition(s):
Heart Failure
Relative bioavailability and food effect study of two new 15 mg vericiguat formulations
Bayer Identifier:
19699
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- For pilot part: Number of subjects with treatment emergent adverse events (TEAEs)Timeframe: 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 vericiguatTimeframe: From pre-dose until 72 h after dosing
- For main part: Maximum observed drug concentration (Cmax) in measured matrix after single dose administration of vericiguatTimeframe: From pre-dose until 72 h after dosing
Secondary Outcome
- For main part: Number of subjects with treatment emergent adverse events (TEAEs)Timeframe: From first application of study intervention up to 30 days after end of treatment with study intervention
Additional Information
Not Available
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