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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRK-750, single and multiple doses | Experimental |
| |
| Placebo, single and multiple doses | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRK-750 | Drug | TRK-750 capsule |
| |
| Placebo |
| 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 |
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Inclusion Criteria:
Male or female volunteers
Female subjects who are either:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | London | United Kingdom |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
Placebo capsule |
|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |