An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study will determine the extent of systemic absorption of HAL following vaginal and enema administration compared to intravenous administration to healthy female volunteers.

In addition, the pharmacokinetic parameters for the combined level of 14C labelled substances (sum of parent and possible metabolites)will be assessed. The safety and tolerability of HAL following vaginal, enema and intravenous administration to healthy female volunteers will be investigated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Photocure
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• healthy women aged 18 to 55 years (inclusive)

• Body Mass Index (BMI) > 19 and < 30 kg/m2

• Able to understand the nature of the study and to give written informed consent

Exclusion Criteria:

• consumption of medication (including 'over the counter' preparations and herbal remedies) within two weeks of dosing. Simple analgesics (e.g. paracetamol) may be allowed at the discretion of the Investigator

• past or current drug exposure amounting to drug abuse or addiction

• past or current alcohol exposure amounting to alcohol abuse or addiction; [i.e. > 21 units per week for females, where 1 unit = one measure of spirit (25 ml), one glass of wine (125 ml) or ½ pint beer]

• smokers of more than five cigarettes a day

• donation of blood within two months before the study

• receipt of a 14C labelled compound in one year before the study

• participation in a clinical trial involving receipt of a licensed or unlicensed medicinal product within three months before the study

• unwilling or unable to comply with the study protocol for any reason

• positive test for hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus (HIV) at screening

• subjects with childbearing potential (i.e. pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive (oral contraception) regimen from the pre-study screening until at least 3 months after the last study period.

• pregnant or lactating women

• clinically relevant abnormalities in the pre-study screening.

• known allergy or intolerance to any compound in the test product or any other closely related compound

• any other acute or chronic disease which could influence the subject's health and/or the study results, e.g. porphyria

• clinically relevant abnormalities from standard gynecological examination (incl. cervical smear and determination of position of uterus)

• Irregular defecation pattern, i.e. less than once per 2 days