None listed
Conditions
Brief summary
This study will assess the effect of ANPA-0073 on the PK of sildenafil (and vice versa) using a single sequence, 3-period design. Participants will receive a single dose of 50 mg sildenafil on Day 1, ANPA-0073 on each Day 2 to 7, single dose of 50 mg sildenafil + single dose of ANPA-0073 on Day 8. The total maximum study duration for participants is 44 days, inclusive of screening and visit windows. For each participant, the confinement period will commence on Day -1, with dosing commencing on Day 1 and continuing to Day 8, and discharge on Day 11. Participants will return to the clinic on Day 15 (± 1 day) for a final EoS visit. It is anticipated that ANPA-0073 will help treat patients with pulmonary arterial hypertension (PAH),. The results from this study will form the basis for further evaluation of ANPA 0073 and dose and formulation selection for future studies.
Interventions
ANPA-0073 oral capsules at the dose strength of 100 mg will be used in this study. Commercially available sildenafil oral tablets (brand name: Viagra®) at the dose strength of 50 mg will be used in this study.
This study will assess the effect of ANPA-0073 on the PK of sildenafil (and vice versa) using a single sequence, 3-period design.
On Day 1 (Period 1), participants will receive a single dose of 50 mg sildenafil. On Days 2-7 (Period 2), participants will receive ANPA-0073, 300-500mg onc
ANPA-0073 oral capsules at the dose strength of 100 mg will be used in this study. Commercially available sildenafil oral tablets (brand name: Viagra®) at the dose strength of 50 mg will be used in this study. This study will assess the effect of ANPA-0073 on the PK of sildenafil (and vice versa) using a single sequence, 3-period design. On Day 1 (Period 1), participants will receive a single dose of 50 mg sildenafil. On Days 2-7 (Period 2), participants will receive ANPA-0073, 300-500mg once daily at about the same time(s) each day. On Day 8 (Period 3) participants will receive concurrent administration of a single dose of ANPA-0073 (dose level TBC) and a single dose of 50 mg sildenafil. Participants will receive study drugs (ANPA-0073 capsules and sildenafil tablets) orally with noncarbonated room temperature water (approximately 240 mL) under the supervision of site staff. The dose level of ANPA-0073, and final dosing schedule (i.e. once or twice daily administration) to be used in this study will be determined from emerging safety and PK data from the ongoing ANPA-0073-01 study. The dose level of ANPA-0073 will not exceed that which has been shown to be safe and well tolerated in the ANPA-0073-01 study. Participants will be discharged on Day 11.
Sponsors
Avance Clinical Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed