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

NCT01050309 | Completed Phase 1

• 1 other identifier: PC CO102/09
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To determine the extent of systemic absorption of HAL following vaginal and enema administration compared to intravenous administration to healthy female volunteers.

Secondary Outcomes (1)

• To determine pharmacokinetic parameters for the combined level of 14C labelled substances. To assess the safety and tolerability of HAL following vaginal, enema and intravenous administration to healthy female volunteers.

Study Arms (3)

Cervix

ACTIVE COMPARATOR

Drug: hexaminolevulinate (HAL)

colon

ACTIVE COMPARATOR

Drug: hexaminolevulinate (HAL)

Intravenous

ACTIVE COMPARATOR

Drug: hexaminolevulinate (HAL)

Interventions

hexaminolevulinate (HAL) DRUG

Intravenous dose of HAL 0.4 mg/kg including 100 nCi (3.7 kBq) 14C infused over a one hour period. A vaginal dose HAL 150 mg including 13,9 kBq of 14C HAL will be administered for 7 hours. Following a colon cleaning, 100mg HAL enema including 14,8 kBq of 14C will be instilled for 30 minutes in colon

Cervix; Intravenous; colon

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Photocure: lead

Study Sites (1)

Pra-Eds-Nl

Zuidlaren, 9471, Netherlands

Location

MeSH Terms

Interventions

5-aminolevulinic acid hexyl ester

Study Officials

• Berit Nicolaisen, M.Sc.

  Photocure ASA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 15, 2010

Record last verified: 2010-01

Locations

NL (1)