angioedema
Conditions
Interventions
PHA-022121 will be given 1 time per period, so 2 times in total. Each dose that
the volunteer will receive is 40 milligrams.
Sponsors
Pharvaris Netherlands BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject must sign an ICF indicating that the subject understands the purpose of the study including the procedures required, potential risks involved, and is willing to participate in the study before starting any screening activities. 2. Adult male or female subjects, between 18 to 65 years of age (inclusive) at the time of informed consent. 3. Subject must have a body mass index (BMI) between 18.0 and 35.0 kg/m2 (inclusive), and a body weight not less than 50.0 kg, inclusive, at screening. 4. A subject may be enrolled if she/he is willing and able to adhere to the contraceptive requirement. 5. All female subjects must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening and at Day -1 of each treatment period. Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Subject has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (estimated creatinine clearance 1.1 x upper limit of normal range [ULN]); - Hemoglobin below lower limit of normal range (LLN) (reference of site ); - Platelet count below LLN; - Absolute neutrophil count lowering grade 1 or greater ( ULN; - Total bilirubin.> ULN; - Any other toxicity grade 2 or above, except for grade 2 elevations for triglycerides, low density lipoprotein (LDL) cholesterol and/or total cholesterol. 3. Subject underwent surgery or has a medical condition that might significantly affect absorption of medicines (e.g., stomach bypass, cholecystectomy, etc.) as judged by the Investigator. 4. Subject has clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the clinical site on Day -1 as judged by the Investigator. 5. Subject, at screening, has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the influence of a high-calorie, high-fat (HCHF) meal on the single-dose pharmacokinetics of a 40 mg extended-release (XR) PHA-022121 oral formulation and its metabolites (e.g. M2-D) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a 40 mg XR formulation of PHA-022121 administered as a single oral dose in the absence and presence of a HCHF meal. | — |
Countries
Netherlands
Outcome results
None listed