check_circleStudy Completed

Clinical pharmacology

Bayer Identifier:

17746

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2016-002330-68

EU CT Number:

Not Available
Drug-drug interaction of vericiguat with rifampicin

Trial purpose

The primary objective was:
• to investigate the influence of multiple doses of 600 mg rifampicin administered once daily on the pharmacokinetics of a single 10 mg dose of vericiguat, in comparison with a single 10 mg dose of vericiguat administered alone.

The secondary objectives were:
• to investigate the influence of multiple doses of 600 mg rifampicin administered once daily on the safety and tolerability of a single 10 mg dose of vericiguat, in comparison with a single 10 mg dose of vericiguat administered alone.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy white male subjects, 18 to 45 years of age (inclusive), body mass index (BMI) ≥18.0 and ≤29.9 kg/m²

  • - Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs would not be normal
    - Known hypersensitivity to the study drugs and derivatives, e.g., other rifamycins (active substances or excipients of the preparations)
    - Known severe allergies, non-allergic drug reactions, or multiple drug allergies
    - Febrile illness within 1 week before the first study drug administration
    - History of postural syncope
    - A history of relevant diseases of vital organs, of the central nervous system or other organs
    - Relevant diseases within the last 4 weeks prior to first study drug administration
    - Medical disorder that would 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, GI bleeding) or inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)

Trial summary

Enrollment Goal
16
Trial Dates
September 2016 - May 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) in Plasma After Single Dose Administration of Vericiguat
    date_rangeTime Frame:
    hour (pre-dose) to 96 hours post-dose of vericiguat in Period 1 and 2
  • Maximum Observed Concentration (Cmax) of Vericiguat in Plasma After Single Dose Administration
    date_rangeTime Frame:
    0 hour (pre-dose) to 96 hours post-dose of vericiguat in Period 1 and 2

Secondary Outcome

  • Number of Subjects With Treatment Emergent Adverse Events
    date_rangeTime Frame:
    From the start of study drug administration up to 30 days after end of study treatment

Trial design

Non-randomized, non-blinded, non-placebo-controlled study with intra-individual comparison to investigate the influence of multiple doses of 600 mg rifampicin once daily on the pharmacokinetics, safety and tolerability of a single oral dose of 10 mg vericiguat (BAY 1021189; IR tablets) in comparison to a single oral dose of 10 mg vericiguat alone in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
1