Hereditary Angioedema
Conditions
Interventions
Day Treatment How often
1 drug cocktail consisting of 50 mg caffeine, 10 mg omeprazole, and 1 mg
midazolam once
3 20 mg PHA-022121 twice daily
drug cocktail consisting of 50 mg caffeine, 10 mg omepr
Sponsors
Pharvaris Netherlands BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be a healthy male or female subject, between 18 to 65 years of age, extremes included, at screening. 2. Subject must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kg/m2, extremes included, and a body weight not less than 50.0 kg, inclusive, at screening. 3. Subject must sign an ICF indicating that he or she understands the purpose of the study including the procedures required, and is willing to participate in the study, including that he /she agrees to provide DNA samples for research, before starting of any screening activities. 4. During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a male subject: - who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use a barrier method of contraception (eg, condom or partner with occlusive cap [diaphragm or cervical/vault caps]). In addition, their female partner should also use a highly effective method of birth control (eg, hormonal contraception , intra-uterine device) for at least the same duration. - Who is sexually active with a woman who is pregnant must use a condom. - Must agree not to donate sperm until 90 days after receiving the last study drug administration.
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 LLN ( reference of site applies for male and female, respectively) lowering grad 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. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the clinical site on Day -1 as deemed appropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the potential inhibitory/inducing effects of multiple doses of PHA 022121 on the single-dose pharmacokinetics (PK) of a cocktail, containing selective probe substrates of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2C19 and CYP3A4) in healthy adult subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are to evaluate the safety and tolerability of PHA 022121 after multiple doses in the presence of a drug cocktail in healthy adult subjects and to assess steady-state PK of PHA-022121 and its active metabolite M2-D in the presence of a drug cocktail in healthy adult subjects. | — |
Countries
Netherlands
Outcome results
None listed