Trial Condition(s):
Clinical Pharmacology
Interaction study vericiguat with Entresto® (sacubitril/valsartan) in healthy male subjects
Bayer Identifier:
17745
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Healthy male subjects with a body mass index above/equal 18.0 and below/equal 29.9 kg / m2 and age from 40 to 60 years (inclusive)
Exclusion Criteria
- Incompletely cured pre-existing diseases which could have altered the absorption, distribution, metabolism, elimination and effects of the study drugs. - Medical disorder with potential to impair the subject’s ability to complete the study in the opinion of the investigator. - Known gastrointestinal (GI) disorders (e.g. stomach ulcers, duodenal ulcers, gastrointestinal bleeding) or inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis). - History of symptomatic postural hypotension (e.g. dizziness, lightheadedness), postural symptoms or syncope. - History of hypotension (anamnestic blood pressure <90/50 mmHg). - History or suspicion of drug and/or alcohol dependencies. - Known hypersensitivity to the study drug (active substance or excipients of the preparations). - Lactose intolerance. - Known severe allergies, non-allergic drug reactions or multiple drug allergies (i.e. angioedema).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Mönchengladbach, Germany, 41061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, single-blind, placebo-controlled interaction study to investigate the influence of co-administration of 2.5 mg vericiguat once daily and Entresto® 97/103 mg (sacubitril/ valsartan) twice daily at steady state on the safety, tolerability, pharmacodynamics and pharmacokinetics in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)Timeframe: 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 PointsTimeframe: 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 PointsTimeframe: 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 PointsTimeframe: 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 PointsTimeframe: 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 PointsTimeframe: 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 PointsTimeframe: 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 DosesTimeframe: 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 DosesTimeframe: 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 PlasmaTimeframe: 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 PlasmaTimeframe: Period 2: Days 26 (entresto alone), 27 and 40 (entresto + vericiguat /placebo)
Additional Information
Not Available
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