A Phase I, two parallel arms, open label, randomized, two period, two-way cross-over study to assess the steady-state pharmacokinetics of a 40 mg PHA-022121 XR tablet administered once daily with the steady-state pharmacokinetics of two 10 mg PHA-022121 IR capsules administered twice daily (Arm 1) and to assess the steady-state pharmacokinetics of 40 mg PHA-022121 XR tablet administered twice daily with the steady-state pharmacokinetics of four 10 mg PHA- 022121 IR capsules administered twice da
- Conditions
- Hereditary Angioedema1001884910027664
- Registration Number
- NL-OMON53813
- Lead Sponsor
- Pharvaris Netherlands BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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 as specified
5. All female subjects must have a negative serum β-human chorionic
gonadotropin (β-hCG) pregnancy test at screening and on Day -1 of each
treatment period.
6. Subject must be willing and able to adhere to the prohibitions and
restrictions as specified
7. Subject must be healthy on the basis of a medical evaluation that reveals
the absence of any clinically significant abnormality at screening per
Investigator discretion.
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 < 62mL/min/1.73m2 at
screening, calculated by MDRD formula), thyroid disease, neurologic or
psychiatric disease, infection, or any other illness, that in the
Investigator*s and/or Sponsor*s medical monitor opinion should exclude the
subject or that could interfere with the interpretation of the study results.
2. Subject has one of the following laboratory abnormalities at screening as
defined by the Common Terminology Criteria for Adverse Events (CTCAE) version
5.0, 27 November 2017 and in accordance with the normal ranges of the clinical
laboratory if no gradings are available.
- Serum creatinine elevation grade 1 or greater (>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 (<=1,5 109/L);
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. ECGs<br /><br>2. vital sign measurements<br /><br>3. PK blood sampling for PHA-022121 and its metabolites (PK blood sampling<br /><br>should be kept as close as possible to the specified time points.)<br /><br>4. safety laboratory samples</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>