Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750
Lead Sponsor:
Toray Industries, Inc
Conditions:
Healthy, Peripheral Neuropathic Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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, ascen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03346330
Start Date
November 21 2017
End Date
August 31 2018
Last Update
December 19 2018
Active Locations (1)
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1
London
London, United Kingdom