Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

NCT02029066 | Completed Phase 1

• 2 other identifiers: GESRTAKC1025023899
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body temperature) will be recorded.

Conditions

Actinic Keratosis

Keywords

actinic keratosis; SR-T100; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To assess the delivery of SR-T100 from the topical gel by determining the plasma solamargine levels in subjects with AK within a 100 cm^2 treatment area.

  Twelve Subjects will participate in this study. Each patient will be taken blood samples (6 ml for each) before and after applying of SR-T100 at 0, 0.5, 1, 1.5, 2,2.5, 3, 4, 5, 6, 8, 10,12,16, 20, 24, 28, 34, and 36 hour. Plasma solamargine will be analyzed from blood samples using a bioanalytical method. Pharmacokinetic parameters such as AUC0-t, AUC0-infinity, Cmax Tmax, T½, λz, clearance and MRT will be calculated from plasma concentrations of solamargine and presented in the final report.

  33 days

Secondary Outcomes (1)

• Safety parameters (medical history, clinical examinations, laboratory tests and adverse events) will be recorded and reported as appropriate.

  33 days and 7 days follow up period after complete study.

Study Arms (1)

SR-T100 gel

EXPERIMENTAL

dosage form: topical gel dosage: 2g of 2.3% SR-T100 frequency: once duration: 24 hours

Drug: SR-T100 gel

Interventions

SR-T100 gel DRUG

2g of SR-T100 will topical apply on 100 cm\^2 once for 24 hours.

SR-T100 gel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female is 20 years of age or above.
• Patient has AK lesions located within a 100 cm2 contiguous or non-contiguous treatment area.
• Patient has at least one clinical confirmed AK lesion within the selected treatment area before.

You may not qualify if:

• Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon, cytotoxic drugs.
• Patient had treated with topical 5-FU, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
• Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
• Patient had received any of the following treatments on the treatment area in the 6 months before study treatment initiation: psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, chemical peel.
• Patient had used any topical preparations, such as sunscreens, moisturizers, body oils, or alpha or beta hydroxyl acids, in the treatment area within 24 hours before and during the study course.
• Use of any medication, including over the counter products, herb medicine and dietary supplements such as vitamins, which would interfere with study results, within one week before and during the study course.
• Patient is known to be hypersensitive to the study medication.
• Female who is pregnant, breast-feeding or considering becoming pregnant while on the study.
• Donation of 500 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
• Patient had used of any investigational drug within the past 30 days before enrollment.
• Patient has any dermatological disease and/or condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area (5 cm distances from treatment area).

Sponsors & Collaborators

• G&E Herbal Biotechnology Co., LTD: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hamm-Ming Sheu, M.D.

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: January 7, 2014
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

TW (1)