NPC-12G Gel 0.2% Sirolimus PK Bridging Study

Bioavailability Study Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972462
• Other study ID #: NPC-12G-4/US
• Status: Completed
• Phase: Phase 1
• Start date: May 31, 2019
• Est. completion date: June 17, 2019

Study information

• Verified date: May 2019
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability Study

Intervention

Drug:
• NPC-12G Gel 0.2%
Period 1
• Rapamune® 2 mg tablet
Period 2

Locations

Country	Name	City	State
United States	InVentiv Health Clinical Research Services LLC	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

United States, 

Outcome

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