Trial Condition(s):

Clinical Pharmacology

Drug-drug interaction of vericiguat with rifampicin

Bayer Identifier:

17746

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2016-002330-68

Study Completed

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.

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
16
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 

Trial Design