Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750
CompletedPhase 1NCT03346330
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- An Exploratory, Randomised, Double-blind, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of TRK-750 in Healthy Adults and Patients With Peripheral Neuropathic Pain
- Conditions
- Healthy, Peripheral Neuropathic Pain
- Interventions
- Drug: TRK-750
- Drug: Placebo
- Sponsor
- Toray Industries, Inc
- Start date
- 2017-11-21
- Primary completion
- 2018-08-31
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03346330