Study 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

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

Trial Dates

September 2016 - May 2017

Phase

Phase 1

Could I Receive a placebo

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
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
Time 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
Time 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
Time 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