Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750
NCT03346330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2018-12-19
Summary
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.
Conditions
- Healthy, Peripheral Neuropathic Pain
Interventions
- DRUG
-
TRK-750
TRK-750 capsule
- DRUG
-
Placebo capsule
Sponsors & Collaborators
-
Toray Industries, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-11-21
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
Countries
- United Kingdom
Study Locations
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