Interaction study with mefenamic acid in healthy male subjects
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.
- 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
- 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
Berlin, Germany, 13353
E-mail: [email protected]
Phone: Not Available
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