check_circleStudy Completed
Clinical pharmacology
Bayer Identifier:
17745
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Interaction study vericiguat with Entresto® (sacubitril/valsartan) in healthy male subjects
Trial purpose
The primary objective of this study was to
- investigate safety and tolerability of co administration of 2.5 mg vericiguat once daily (od) and sacubitril and valsartan 97/103 mg twice daily (bid) over 14 days at steady state.
The secondary objectives of this study were to
- assess pharmacodynamic interaction of co-administration of 2.5 mg vericiguat (od) and sacubitril and valsartan 97/103 mg (bid) over 14 days at steady state.
- investigate the pharmacokinetic interaction potential of co-administration of 2.5 mg vericiguat (od) and sacubitril and valsartan 97/103 mg (bid) over 14 days at steady state.
- investigate safety and tolerability of co administration of 2.5 mg vericiguat once daily (od) and sacubitril and valsartan 97/103 mg twice daily (bid) over 14 days at steady state.
The secondary objectives of this study were to
- assess pharmacodynamic interaction of co-administration of 2.5 mg vericiguat (od) and sacubitril and valsartan 97/103 mg (bid) over 14 days at steady state.
- investigate the pharmacokinetic interaction potential of co-administration of 2.5 mg vericiguat (od) and sacubitril and valsartan 97/103 mg (bid) over 14 days at steady state.
Key Participants Requirements
Sex
MaleAge
40 - 60 YearsTrial summary
Enrollment Goal
32Trial Dates
April 2016 - September 2016Phase
Phase 1Could I Receive a placebo
YesProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mönchengladbach, 41061, Germany |
Primary Outcome
- 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
- Maximum Decrease in Seated Mean Systolic Blood Pressure During Hemodynamic Profiles at Specified Time Pointsdate_rangeTime Frame:Period 1: Day 0; Period 2: Days 0, 14, 26, 27 and 40
- Maximum Decrease in Seated Mean Diastolic Blood Pressure During Hemodynamic Profiles at Specified Time Pointsdate_rangeTime Frame:Period 1: Day 0; Period 2: Days 0, 14, 26, 27 and 40
- Maximum Increase in Seated Mean Heart Rate During Hemodynamic Profiles at Specified Time Pointsdate_rangeTime Frame:Period 1: Day 0; Period 2: Days 0, 14, 26, 27 and 40
Secondary Outcome
- Mean Change in Seated Systolic Blood Pressure During Hemodynamic Profiles at Specified Time Pointsdate_rangeTime Frame:Period 1: Day 0; Period 2: Days 0, 14, 26, 27 and 40
- Mean Change in Seated Diastolic Blood Pressure During Hemodynamic Profiles at Specified Time Pointsdate_rangeTime Frame:Period 1: Day 0; Period 2: Days 0, 14, 26, 27 and 40
- Mean Change in Seated Heart Rate During Hemodynamic Profiles at Specified Time Pointsdate_rangeTime Frame:Period 1: Day 0; Period 2: Days 0, 14, 26, 27 and 40
- Maximum Observed Drug Concentration (Cmax) of Vericiguat in Plasma Following Single and Multiple Dosesdate_rangeTime Frame:Period 1: Day 0 (vericiguat alone); Period 2: Days 27, 40 (Entresto + vericiguat)
- Area Under the Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of Vericiguat in Plasma Following Single and Multiple Dosesdate_rangeTime Frame:Period 1: Day 0 (vericiguat alone); Period 2: Days 27, 40 (Entresto + vericiguat)
- Maximum Observed Drug Concentration After Multiple Dose Administration (Cmax,md) of Sacubitril, LBQ657, and Valsartan (After Morning Doses) in Plasmadate_rangeTime Frame:Period 2: Days 26 (entresto alone), 27 and 40 (entresto + vericiguat /placebo)
- Area Under the Concentration Versus Time Curve From Zero to 12 Hours After Multiple Dose (AUC[0-12])md of Sacubitril, LBQ657, and Valsartan in Plasmadate_rangeTime Frame:Period 2: Days 26 (entresto alone), 27 and 40 (entresto + vericiguat /placebo)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
N/ATrial Arms
2