check_circleStudy Completed
Heart failure
Bayer Identifier:
19699
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
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.
• 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
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
36Trial Dates
February 2019 - April 2019Phase
Phase 1Could I Receive a placebo
NoProducts
Vericiguat (BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
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 vericiguatdate_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 vericiguatdate_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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
N/ATrial Arms
2