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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Healthy, Peripheral Neuropathic Pain

Intervention / Treatment
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* Drug: TRK-750
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers Female subjects who are either: Non-childbearing potential, or permanently sterile OR 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRK-750, single and multiple doses<br> | Drug: TRK-750<br>* TRK-750 capsule<br>|
| Placebo Comparator: Placebo, single and multiple doses<br> | Drug: Placebo<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03 |  | Up to 10-14days after last dose | 
| Proportion of subjects with clinically significant changes in laboratory safety tests |  | Up to 10-14days after last dose | 
| Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram |  | Up to 10-14days after last dose | 
| Proportion of subjects with clinically significant changes in electrocardiogram time intervals |  | Up to 10-14days after last dose | 
| Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg) |  | Up to 10-14days after last dose | 
| Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg) |  | Up to 10-14days after last dose | 
| Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm) |  | Up to 10-14days after last dose | 
| Proportion of subjects with clinically significant changes in vital signs:body temperature(°C) |  | Up to 10-14days after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Neuropathic pain