A phase I, open-label, randomized, two period, two-way cross over study to assess the influence of a high-calorie, high fat meal on the bioavailability of a 40 mg extended release PHA 022121 oral formulatio
- Conditions
- angioedema1001884910027664
- Registration Number
- NL-OMON53489
- Lead Sponsor
- Pharvaris Netherlands BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
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 < 62 mL/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.
Further criteria apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> To assess the influence of a high-calorie, high-fat (HCHF) meal on the<br /><br>single-dose pharmacokinetics of a 40 mg extended-release (XR) PHA-022121 oral<br /><br>formulation and its metabolites (e.g. M2-D)</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of a 40 mg XR formulation of PHA-022121<br /><br>administered as a single oral dose in the absence and presence of a HCHF meal.</p><br>