NPC-12G Gel 0.2% Sirolimus PK Bridging Study

NCT ID: NCT03972462

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2019-06-17

Brief Summary

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

Conditions

Bioavailability Study

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

NPC-12G Gel 0.2% (Period 1)

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

Group Type: EXPERIMENTAL

NPC-12G Gel 0.2%

Intervention Type: DRUG

Period 1

Rapamune Tablet (Period 2)

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

Group Type: ACTIVE_COMPARATOR

Rapamune® 2 mg tablet

Intervention Type: DRUG

Period 2

Interventions

NPC-12G Gel 0.2%

Period 1

Intervention Type: DRUG

Rapamune® 2 mg tablet

Period 2

Intervention Type: DRUG

Other Intervention Names

2 mg of sirolimus in 1 g of gel; Sirolimus

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

InVentiv Health Clinical Research Services LLC

Miami, Florida, United States

Countries

United States

Other Identifiers

NPC-12G-4/US

Identifier Type: -

Identifier Source: org_study_id