A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study of Topical Pirenzepine in Healthy Volunteers

• Register: ANZCTR
• Last refreshed on: 18 April 2017
• Main ID: ACTRN12617000535370
• Date of registration: 12/04/2017
• Prospective Registration: Yes
• Primary sponsor: WinSanTor Australia Pty Ltd
• Public title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study of Topical Pirenzepine in Healthy Volunteers
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study of Topical Pirenzepine in Healthy Volunteers
• Date of first enrolment: 10/05/2017
• Target sample size: 24
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000535370.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Other
• Phase: Phase 1

Health Condition(s) or Problem(s) studied

Diabetic Peripheral Neuropathy

Intervention(s)

This is a Phase 1, first in human, double-blind, randomized, placebo-controlled, multiple dose study consisting of a total of 24 healthy subjects: 3 cohorts of 8 subjects (6 subjects assigned to pirenzepine: 2 assigned to placebo in each cohort).
Each treatment will be administered topically to the lower extremities (right and left calves [i.e., anterior lower leg/shins] and tops of feet) by study staff using gloved hands.
The names of the 2 formulations that will be used are WinF90 (6.5% pirenzepine) and WinFB34 (4.0% pirenzepine).
Cohort 1 will be administered 6.5% pirenzepine topical solution WinF90 or matching placebo – 5 mL applied once daily for 14 days.
Cohort 2 will be administered 4.0% pirenzepine topical solution WinFB34 or matching placebo – 5 mL applied once daily for 14 days.
Cohort 3 will be administered 4.0% pirenzepine topical solution WinFB34/matching placebo or 6.5% pirenzepine topical solution WinF90/matching placebo – administered for 14 days with dose volume and dose frequency to be determined following review of Cohort 1 and 2 data.