Hereditary Angioedema
Conditions
Interventions
PHA-022121 will be given twice as a solution via the mouth using a syringe.
Then the volunteer will be given 240 milliliter (mL) of water which the
volunteer should drink. Itraconazole will be given
Sponsors
Pharvaris 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 60 years of age, extremes included, at screening. 2. Subject must have a body mass index 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 understands the purpose of the study including the procedures required, and is willing to participate in the study, including that he 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) 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. 5. A female subject must be of non-childbearing potential at screening, defined as: - Postmenopausal. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level at screening (>33.4 IU/L ) in the postmenopausal range may be used to confirm a postmenopausal state in woman not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. - Permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.
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 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 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. 4. Subject has a positive test of human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies. 5. Subject has a history of heart arrhythmias, tachycardia at rest, or history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT syndrome).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary PK parameters are Cmax, AUClast, and AUC* of the PHA-022121. All parameters will be analyzed on a logarithmic scale. AUC* will be rejected as primary parameter for a treatment if more than half of the subjects do not have a reliable value for that treatment. | — |
Countries
Netherlands
Outcome results
None listed