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
Overview
- Phase
- Phase 1
- Intervention
- TRK-750
- Conditions
- Healthy, Peripheral Neuropathic Pain
- Sponsor
- Toray Industries, Inc
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Proportion of subjects with clinically significant changes in laboratory safety tests
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
TRK-750, single and multiple doses
Intervention: TRK-750
Placebo, single and multiple doses
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of subjects with clinically significant changes in laboratory safety tests
Time Frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm)
Time Frame: Up to 10-14days after last dose
Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03
Time Frame: Up to 10-14days after last dose
Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram
Time Frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg)
Time Frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in electrocardiogram time intervals
Time Frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg)
Time Frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:body temperature(°C)
Time Frame: Up to 10-14days after last dose