A Randomized, Single-Dose and Multiple Dose Dose-Ranging Safety and Pharmacokinetics Study of Tacrolimus Powder for Inhalation in Healthy Adult Subjects
- Conditions
- Inflammatory and Immune System - Other inflammatory or immune system disordersRespiratory - Other respiratory disorders / diseasesProphylactic therapy of organ rejection in patients receiving allogeneic lung transplants
- Registration Number
- ACTRN12620000192987
- Lead Sponsor
- TFF Pharmaceuticals Australia Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
1. Healthy, adult, male or female (women of non-child bearing potential only),
2. Continuous non smoker who has not used nicotine containing products (including e vaping) for at least 3 months prior to the first dosing and throughout the study, based on subject’s self-reporting and urine cotinine levels at screening.
3. Medically healthy with no clinically significant medical history, physical and neurologic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
4. A CKD-EPI Creatinine 2009 estimated creatinine clearance of >=80 mL/min
5. A non vasectomized, male subject must agree to use a highly effective method of birth control with female partners of childbearing potential during the study and for 120 days following dosing.
1. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
2. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
3. History or presence of hypersensitivity or idiosyncratic reaction to tacrolimus, cyclosporine, or any chemically related compound (everolimus, sirolimus).
4. History of lactase deficiency
5. Has had surgery or any medical condition within 6 months prior to first dosing which may affect the absorption, distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.
6. Female subjects with a positive pregnancy test or who are lactating.
7. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
8 ECG findings are abnormal.
9. Blood pressure is abnormal.
10. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method