check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
15841
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Interaction study of vericiguat with digoxin in healthy male subjects
Trial purpose
The primary objective of this study was to investigate the influence of a concomitant intake of multiple doses of 10 mg vericiguat administered once-daily (od) for 9 days on the steady state PK of digoxin (0.375 mg od).
The secondary objective of this study was to assess the safety and tolerability of the combined administration of both drugs and to determine the influence of multiple doses of digoxin (0.375 mg od) on the PK of a single dose of 10 mg vericiguat.
The secondary objective of this study was to assess the safety and tolerability of the combined administration of both drugs and to determine the influence of multiple doses of digoxin (0.375 mg od) on the PK of a single dose of 10 mg vericiguat.
Key Participants Requirements
Sex
MaleAge
18 - 55 YearsTrial summary
Enrollment Goal
25Trial Dates
April 2015 - April 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mannheim, 68167, Germany |
Primary Outcome
- Area Under the Concentration Versus Time Curve During Dose Interval After Multiple Dose (AUCtau,md) From 0 Hour (Pre-dose) to 24 Hours Post-dose on Day 10 of Digoxin in Plasmadate_rangeTime Frame:0 hour (pre-dose) to 24 hours post-dose on Day 10 of Period 2 and 3
- Through Concentration of Digoxin in Plasma (Ctrough) on Day 8, Day 9 and Day 10 of Digoxin Administrationdate_rangeTime Frame:0 hour (pre-dose) to 24 hours post-dose on Day 8, 9, 10 of Period 2 and 3
Secondary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Vericiguat in Plasmadate_rangeTime Frame:0 hour (pre-dose) to 48 hours post-dose on Day 1 of Period 1 and Period 3
- Maximum Observed Drug Concentration (Cmax) of Vericiguat in Plasmadate_rangeTime Frame:0 hour (pre-dose) to 48 hours post-dose on Day 1 of Period 1 and Period 3
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)date_rangeTime Frame:From start of study drug administration until 30 days post study treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
N/ATrial Arms
2