Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers

NCT01490008 | Completed Phase 1

• 2 other identifiers: CT 10232011-004857-20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of systemic catechin exposure following topically administered Veregen® 15% ointment in patients with external genital and perianal warts and following oral intake of a standardized green tea beverage in healthy subjects. Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin exposure following dermal administration in the patient group will only be calculated if sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations. If applicable, a safety margin for ointment use might need to be established with respect to intolerable systemic exposures of catechins following application of Veregen® ointment. In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg three times daily: in the morning, at midday, and in the evening on the defined anogenital administration area (total dose of 750 mg/d) for one week . In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea beverage ("Lipton® Green Limone" distributed by PepsiCo Deutschland GmbH, Neu-Isenburg, Germany), three times daily in the morning, at midday, and in the evening (total dose of 1500 mL/d) for one week. Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24 hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first dosing). To avoid any influence on overall systemic catechin exposure deriving from any other source than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages known to containing catechins (a list of all prohibited and allowed foods and beverages will be provided to all subjects). For concomitant medication, only paracetamol and oral contraceptives are allowed.

Conditions

Anogenital Warts

Outcome Measures

Primary Outcomes (1)

• Systemic exposure of green tea catechin EGC

  The primary objective of this trial is to investigate the systemic exposure, and, if possible, the plasma concentrations and pharmacokinetics of green tea catechin EGCg after topically applied Veregen® 15% ointment in patients with external genital warts and that following oral intake of commercially available green tea beverage by healthy subjects. On the sampling Days 1/2 and 7/8, blood samples of 3 mL each will be collected (non-fasting condition) at specified time points (see above)

  At time points 0, i.e. prior to the morning ingestion of 500 mL of commercial green tea beverage or the morning application of 250 mg Veregen® 15%, and 0.5, 1, 2, 4, 6, 8, 10, 12, 14, and 24 hours afterwards.

Study Arms (2)

Veregen

EXPERIMENTAL

Veregen® (sinecatechins) Ointment, 15%, local application of 250 mg corresponding to 0.5 cm strand of ointment, 3 times daily (total dose of 750 mg/d)

Drug: Veregen

Tea

ACTIVE COMPARATOR

"Lipton® Green Limone", a green tea beverage; oral intake of 500 mL green tea, 3 times daily (total dose on 1500 mL/d)

Other: Green Tea

Interventions

Veregen DRUG

Patients in treatment arm 1 will apply Veregen® 15% ointment (approved commercial source in US) in a total of 750 mg/day for one week, corresponding to application of maximal about 106,9 mg catechins/d, thereof maximal 81 mg ECGg per day). Patients will be instructed to apply fix portions of 250 mg three times daily on the defined anogenital administration area.

Veregen

Green Tea OTHER

Healthy volunteers in treatment arm 2 will drink "Lipton® Green Limone" in a total of 1500 mL/d for one week, in portions of 500 mL three times daily after the meals

Tea

Eligibility Criteria

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

You may qualify if:

• For both subject groups (treatment arms 1 + 2):
• Male and female subjects, 18 years of age or older at the time of enrollment. Subjects will be stratified by gender.
• Written informed consent.
• Ability to comply with the requirements of the study.
• For male patients and partners of male patients who are of child-bearing potential: use of two methods of effective contraception (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant or sterilization plus condom during the treatment period is mandatory.
• For women a negative pregnancy test and the willingness to use two methods of effective contraception (oral contraceptives, hormone containing intrauterine device, depot injection, hormone implant or sterilization plus condom during the treatment period is mandatory.
• For patients (treatment arm 1, additionally):
• Clinical diagnosis of external genital and perianal warts which can be located: in men: over the glans penis, foreskin, penis shaft, and scrotum; in women: on the vulva; in both gender: in the inguinal, perineal, and perianal areas
• For women a negative pregnancy test and willingness to abstain from cohabitation during the treatment phase.
• For male patients willingness to abstain from cohabitation during the treatment phase.

You may not qualify if:

• For both subject groups (treatment arms 1 + 2):
• Participation in an investigational trial within 30 days prior to enrollment and for the whole study duration
• Any current uncontrolled infection
• Current known acute or chronic infection with Hepatitis virus B or C
• Known Human immunodeficiency virus infection
• Subjects with known history of instable diseases (diabetes, hypertension, etc.), severe gastritis or consuming diseases (cancer, multiple sclerosis, etc.), or liver or renal insufficiency.
• Any chronic or acute condition including the skin, susceptible, in the opinion of the investigator, of interfering with the evaluation of the drug effect
• Subject with any of the following:
• quantitative hematology values deviating more than 20% of upper or lower normal values
• clinical chemistry except electrolytes and liver enzymes deviating more than 50% of upper or lower normal values
• liver enzymes exceeding twice the upper limit of normal range (ULN)
• serum electrolytes deviating more than 20% of upper or lower normal values
• abnormal results in urine supported by clinical evidence
• laboratory values out of normal range and showing corresponding clinical signs or symptoms
• Systemic intake of virostatics within 30 days prior to enrollment and for the whole study duration, with the exception of acyclovir and the related drugs famcyclovir and valcyclovir

Sponsors & Collaborators

• MediGene: lead

Study Sites (1)

CardioSec Clinical Reasearch GmbH

Erfurt, 99084, Germany

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

green tea extract polyphenone E; Tea

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

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

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 12, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

DE (1)