NPC-12G Gel 0.2% Sirolimus PK Bridging Study

NCT03972462 | Completed Phase 1 FDA Drug

• 1 other identifier: NPC-12G-4/US
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioavailability Study

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

NPC-12G Gel 0.2% (Period 1)

EXPERIMENTAL

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

Drug: NPC-12G Gel 0.2%

Rapamune Tablet (Period 2)

ACTIVE COMPARATOR

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

Drug: Rapamune® 2 mg tablet

Interventions

NPC-12G Gel 0.2% DRUG

Period 1

Also known as: 2 mg of sirolimus in 1 g of gel

NPC-12G Gel 0.2% (Period 1)

Rapamune® 2 mg tablet DRUG

Period 2

Also known as: Sirolimus

Rapamune Tablet (Period 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (1)

InVentiv Health Clinical Research Services LLC

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Sirolimus; Gels; Tablets

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 3, 2019
• Study Start: May 31, 2019
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: March 6, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)