Safety and Pharmacokinetics of PL265 in healthy males (QCL117989)
Research type
Research Study
Full title
Phase Ib, randomised, double-blind, placebo-controlled multiple oral dose escalation study to assess the safety, tolerability and pharmacokinetics of PL265 in healthy male volunteers
IRAS ID
226664
Contact name
Michel WURM, M.D.
Contact email
Sponsor organisation
Pharmaleads
Eudract number
2017-001283-38
Duration of Study in the UK
0 years, 4 months, 19 days
Research summary
The Sponsor is developing the test medicine, PL265, for the potential treatment of neuropathic pain. Neuropathic pain is pain caused by damage or disease affecting the nerves.
The purpose of the study is to assess the safety and tolerability of the test medicine after multiple dosing occasions. The study will also determine how the test medicine is taken up by the body after multiple dosing occasions.
This is a single period study involving up to 40 healthy male volunteers. The 40 volunteers will be divided into 5 groups (Cohort 1 to 5) each made up of 8 volunteers (6 receiving test medicine and 2 receiving placebo). Each volunteer will receive a single oral dose (solution) of test medicine or placebo either once or twice a day for four consecutive days and each group will receive a different amount of the test medicine. The maximum planned dose is 600 mg per day.
Blood and urine samples will be collected at specific times throughout the study to look at the amount of test medicine in the body. Cohorts 4 and 5 will also undergo a lumbar puncture procedure to look at the amount of the drug in the spinal fluid.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0226
Date of REC Opinion
7 Jul 2017
REC opinion
Further Information Favourable Opinion