NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Sirolimus From Topical Application of NPC-12G Gel to Oral Rapamune® Following Single Administration in Healthy Subjects Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03972462

Enrollment

Registered

2019-06-03

Start date

2019-05-31

Completion date

2019-06-17

Last updated

2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability Study

Brief summary

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

Interventions

DRUGNPC-12G Gel 0.2%

Period 1

DRUGRapamune® 2 mg tablet

Period 2

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC0-48	Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Cmax	Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose
Tmax	Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026