NPC-12G Gel 0.2% Sirolimus PK Bridging Study
Completed · Phase 1
Conditions studied: Bioavailability Study
In brief
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
Key facts
- Study ID
- NCT03972462
- Run by
- Nobelpharma
- People needed
- 12
- Starts
- 2019-05-31
- Expected to finish
- 2019-06-17
- Last updated by the study team
- 2020-03-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, non-smoker (no use within 3 months prior to screening), ≥ 18 and ≤ 65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of acceptable contraceptive method throughout the study and for 12 weeks after the last study drug administration
You may not qualify if…
- Any sign of eczema/dermatitis, skin lesion, wound, or infection at the application site, or any other conditions that would prevent a safe application of the gel formulation.
- Laser or surgery at the gel application site within 2 weeks before the gel application.
- Positive alcohol breath test, urine drug screen or urine cotinine test at screeningation
- History of allergic reactions or hypersensitivity to sirolimus, sirolimus derivatives, or excipient of NPC-12G Gel
- Use of any drugs known to induce or inhibit CYP3A4 metabolism within 30 days prior to the first study drug administration
- Positive pregnancy test at screening
- Breast-feeding subject
- History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening
- Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection
- Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study and up to 3 weeks after the last study drug administration
Where it is running
- InVentiv Health Clinical Research Services LLC — Miami, Florida, United States
Full record on ClinicalTrials.gov
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