check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

17745

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2015-004809-16

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.

Key Participants Requirements

Sex

Male

Age

40 - 60 Years
  • - 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)

  • - 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
32
Trial Dates
April 2016 - September 2016
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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 Points
    date_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 Points
    date_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 Points
    date_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 Points
    date_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 Points
    date_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 Points
    date_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 Doses
    date_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 Doses
    date_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 Plasma
    date_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 Plasma
    date_rangeTime Frame:
    Period 2: Days 26 (entresto alone), 27 and 40 (entresto + vericiguat /placebo)

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