Safety, tolerability, PK, PD, food-effect of SAD and MAD of TRK-750
Research type
Research Study
Full title
An exploratory, randomised, double-blind, placebo-controlled, Phase I study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effect of single and multiple, ascending oral doses of TRK-750 in healthy adults and patients with peripheral neuropathic pain.
IRAS ID
232553
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Toray Industries, Inc.
Eudract number
2017-002229-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 24 days
Research summary
We are conducting a first-in-human clinical study of TRK-750 in healthy and patient volunteers. TRK-750 is being developed by Toray Industries, Inc. as a treatment for peripheral neuropathic pain (PNP). PNP is chronic pain caused by damage or disease of the peripheral nerves, either from conditions such as diabetes mellitus or following injuries or operations. PNP can be very difficult to treat, with existing pain killers and treatments are frequently ineffective. TRK-750 is a new small molecule compound that (in laboratory tests) demonstrated analgesic effects without other central nervous system adverse effects.\n\nIn this double-blind, placebo-controlled study we will assess the safety, tolerability and pharmacokinetics (PK) of TRK-750 when administered orally as capsules to healthy volunteers. Initially, 72 healthy Caucasian volunteers will be recruited into the study in the following study parts: Part I, single ascending doses (5 cohorts of 8 volunteers); Part II, food effect (1 cohort of 8 volunteers, open-label and cross-over design) and Part IIIA, multiple ascending doses (3 cohorts of 8 volunteers). In Part IIIB, to enable ethnic comparison of safety, tolerability and PK data, 24 healthy Japanese volunteers will be recruited into 3 combined single and multiple ascending dose cohorts (8 volunteers each). Optional cohorts in Parts I and III may be used to explore additional dose levels. In Part IV, 120 patients with PNP will be recruited to allow an early assessment of the effectiveness of TRK-750 in treating PNP (pharmacodynamics) and the relationship between PK and pharmacodynamics (PD).\n\nWe will collect blood and urine samples for PK measurements. We will assess safety parameters including physical examination, vital sign measurements, laboratory evaluations, electrocardiogram (ECG) and monitoring of adverse events (AEs). PD will be assessed in Part IV using pain scores, non-invasive pain and hypersensitivity tests and quality of life assessments.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0390
Date of REC Opinion
2 Oct 2017
REC opinion
Further Information Favourable Opinion