A Phase I, Open Label Study to Evaluate the Drug-Drug Interaction (DDI) of ANPA-0073 and Sildenafil in Healthy Subjects
- Conditions
- Pulmonary arterial hypertension (PAH)Cardiovascular - Hypertension
- Registration Number
- ACTRN12622000657729
- Lead Sponsor
- Avance Clinical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 16
Healthy Volunteers may be included if they satisfy at least the following key criteria:
1. Body mass index greater than or equal to 18.0 and less than or equal to 30.0 kg/m2, with a body weight (to 1 decimal place) greater than or equal to 45 kg at screening.
2. Be non-smokers (including tobacco and e-cigarettes) for at least 3 months prior to first study drug administration and have a negative test for carbon monoxide (breath test) at the screening visit and at check-in on Day -1.
3. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing at the timepoints
4. Female volunteers must:
a. Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone level greater than 40 IU/L at the screening visit), or
b. If of childbearing potential (and not exclusively in same-sex relationships), must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.
5. Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
Healthy volunteers will be excluded if there is evidence of any of the following at the screening visit or prior to dosing at the timepoints
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological,gastrointestinal, endocrine, immunologic, psychiatric, dermatologic or neurological disease , including anyacute illness or major surgery within the past 3 months determined by the PI to be clinically significant
2. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviralmedications.
3. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell orbasal cell carcinoma).
4. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiencyconditions such as common variable hypogammaglobulinemia.
5. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine,cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months priorto the first study drug administration.
6. History of risk factors for torsade de pointes (including a family history of long QT syndrome or suddencardiac death) or a known arrythmia.
7. History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week orregularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of purealcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40%Alc./Vol]) within 12 weeks prior to the screening visit.
8. Positive drugs of abuse or alcohol breath test results at the screening visit or at check-in (Day -1).
9. Use of any prescription or over-the-counter medication (including herbal products, diet aids, andhormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to thefirst study drug administration, except use of contraceptives and occasional use of paracetamol (doses of500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days) or ibuprofen (upto a maximum of 4 doses of 200 mg per day).
10. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrineadministration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in theopinion of the Investigator, would interfere with the volunteer’s ability to participate in the trial.
11. Have received any vaccinations within 14 days prior to the first study drug administration.
12. For women of childbearing potential, a positive serum pregnancy test at the screening visit or a positiveurine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).
13. Females who are breastfeeding or planning to breast feed at any time during the study.
14. Participation in another clinical trial of where an investigational drug was administered, within 5 half-lives of the investigational agent (whichever is longer) prior to the first study drug administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method