Trial Condition(s):
Clinical Pharmacology
Interaction study with mefenamic acid in healthy male subjects
Bayer Identifier:
17116
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of this study was to investigate the influence of a starting dose of 500 mg followed by multiple doses of 250 mg mefenamic acid every 6 hours on the PK of 2.5 mg vericiguat given as a single oral dose in comparison to 2.5 mg vericiguat given alone.
The secondary objective of this study was to assess the influence of a starting dose of 500 mg followed by multiple doses of 250 mg mefenamic acid every 6 hours on the safety and tolerability of 2.5 mg vericiguat given as a single oral dose in comparison to 2.5 mg vericiguat given alone.
Inclusion Criteria
- Healthy male subject - Age: 18 to 55 years (inclusive) at the first screening examination / visit - Race: White - Body mass index (BMI): above/equal 18 and below/equal 30 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 GI disorders (eg stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (eg Crohn’s disease, ulcerative colitis) - Subjects with thyroid disorders - Known hypersensitivity to the study drug (active substances or excipients of the preparations) or to mefenamic acid - Known hypersensitivity or bronchospasm to acetylsalicylic acid or other NSAIDs - Known severe allergies, non-allergic drug reactions, or multiple drug allergies - Subjects with Gilbert’s syndrome (associated with the UGT1A1 promoter genotype) - Past or present hepatic impairment - Past or present renal impairment - Past or present diagnosed malignancy
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Interaction study to investigate the influence of a starting dose of 500 mg followed by multiple doses of 250 mg mefenamic acid every 6 hours on pharmacokinetics as well as safety and tolerability of a single dose of 2.5 mg vericiguat in comparison to a single dose of 2.5 mg vericiguat alone in healthy male subjects in a randomized, non-blinded, non-placebo-controlled, two-fold cross-over design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Vericiguat in PlasmaTimeframe: 0 hours (h) (pre-dose) to 72 h post-dose
- Maximum Observed Drug Concentration (Cmax) of Vericiguat in PlasmaTimeframe: 0 h (pre-dose) to 72 h post-dose
Secondary Outcome
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEsTimeframe: From start of study drug administration until last follow-up visit (approximately 8 weeks)
Additional Information
Not Available
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