Clincosm LogoSign in Get a demo

NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Sponsor
Nobelpharma (Industry)
Overall Status
Completed
CT.gov ID
NCT03972462
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
17
Actual Duration (Days)
21.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: NPC-12G Gel 0.2%
  • Drug: Rapamune® 2 mg tablet
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
May 31, 2019
Actual Primary Completion Date :
Jun 17, 2019
Actual Study Completion Date :
Jun 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: NPC-12G Gel 0.2%
Period 1
Other Names:
  • 2 mg of sirolimus in 1 g of gel

    		•
    Active Comparator: Rapamune Tablet (Period 2)

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

    Drug: Rapamune® 2 mg tablet
    Period 2
    Other Names:
  • Sirolimus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC0-48 [Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose]

    2. Cmax [Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose]

    3. Tmax [Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 InVentiv Health Clinical Research Services LLC Miami Florida United States 33136

    Sponsors and Collaborators

    • Nobelpharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nobelpharma
    ClinicalTrials.gov Identifier:
    NCT03972462
    Other Study ID Numbers:
    • NPC-12G-4/US
    First Posted:
    Jun 3, 2019
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sirolimus

    Study Results

    No Results Posted as of Mar 6, 2020