Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750

Toray Industries, Inc105 enrolled

Overview

This is 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Healthy, Peripheral Neuropathic Pain

Interventions

TRK-750DRUG

TRK-750 capsule

PlaceboDRUG

Placebo capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female volunteers * Female subjects who are either: 1. Non-childbearing potential, or permanently sterile OR 2. Childbearing potential and agree to use at least one form of highly effective contraception * Male subjects, with a female sexual partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least three months after the end of the systemic exposure of the study drug. * Satisfactory medical assessment with no clinically significant or relevant abnormalities. * Ability to provide written, personally signed, and dated informed consent. Exclusion Criteria: * Current or recurrent disease * Current or relevant history of physical or psychiatric illness * Positive test for Hepatitis B, Hepatitis C or human immunodeficiency virus antibody (HIV) at screening.

Locations (1)

London

London, United Kingdom