Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

An Open-label, Single Dose, Pharmacokinetic Study of SR-T100 Gel (Containing 2.3% Solamargine in Solanum Undatum Plant Extract) in Patients With Actinic Keratosis

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: SR-T100 gel

Detailed Description

In the study period, a single dose of 2 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 100 cm2 skin area covered by an occlusive dressing will be administered. Sampling Time Schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 20, 24, 36 hours after dosing.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon, cytotoxic drugs.
2. 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.
3. Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
4. 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.
5. 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.
6. 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.
7. Patient is known to be hypersensitive to the study medication.
8. Female who is pregnant, breast-feeding or considering becoming pregnant while on the study.
9. 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.
10. Patient had used of any investigational drug within the past 30 days before enrollment.
11. 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).

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SR-T100 gel; dosage form: topical gel dosage: 2g of 2.3% SR-T100 frequency: once duration: 24 hours	Drug: SR-T100 gel; 2g of SR-T100 will topical apply on 100 cm^2 once for 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters (medical history, clinical examinations, laboratory tests and adverse events) will be recorded and reported as appropriate.	Medical history: medical and personal histories will be evaluated by investigators in order to determine whether the subject fulfills the inclusion/exclusion criteria. Clinical examinations: vital signs and physical examinations. Blood pressure, heart rate, body temperature in the sitting position, body weight, and height will be measured. Laboratory tests: Hematology (Hemoglobin, hematocrit, WBC count with differential, RBC count, and platelet count), Biochemistry (Total protein, SGOT (AST), SGPT (ALT), γ-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine, uric acid, total cholesterol, and TG), Urinalysis (Specific gravity, ketone body, urine bilirubin, urobilinogen, leukocyte, nitrite, pH, occult blood, glucose, and protein), Serology (Anti-HIV test, HBsAg and Anti-HCV), and Pregnancy test (Urine or serum pregnancy test (for female patients with childbearing potential)).	33 days and 7 days follow up period after complete study.

Collaborators and Investigators

• Sponsor: G&E Herbal Biotechnology Co., LTD
• Investigators: Principal Investigator: Hamm-Ming Sheu, M.D., National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: January 5, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; actinic keratosis; SR-T100
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: GESRTAKC; 1025023899 (Other Identifier: TFDA)