Trial Condition(s):
Clinical Pharmacology
Drug-drug interaction of vericiguat with rifampicin
Bayer Identifier:
17746
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
N/A
Trial Purpose:
Basic Science
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) in Plasma After Single Dose Administration of VericiguatTimeframe: 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 AdministrationTimeframe: 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 EventsTimeframe: From the start of study drug administration up to 30 days after end of study treatment
Additional Information
Not Available
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