NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Bioavailability Study

Treatments: Drug: NPC-12G Gel 0.2%; Drug: Rapamune® 2 mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03972462

NPC-12G-4/US

Details and patient eligibility

About

This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

NPC-12G Gel 0.2% (Period 1)

Experimental group

Description:

A single 800 mg quantity weight (1.6 mg sirolimus) dose will be applied to the central face on Day 1.

Treatment:

Drug: NPC-12G Gel 0.2%

Rapamune Tablet (Period 2)

Active Comparator group

Description:

Rapamune® (sirolimus) 2 mg tablet for oral dosing.

Treatment:

Drug: Rapamune® 2 mg tablet