Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750
NCT ID: NCT03346330
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
105 participants
INTERVENTIONAL
2017-11-21
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TRK-750, single and multiple doses
TRK-750
TRK-750 capsule
Placebo, single and multiple doses
Placebo
Placebo capsule
Interventions
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TRK-750
TRK-750 capsule
Placebo
Placebo capsule
Eligibility Criteria
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Inclusion Criteria
* Female subjects who are either:
1. Non-childbearing potential, or permanently sterile OR
2. 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 relevant history of physical or psychiatric illness
* Positive test for Hepatitis B, Hepatitis C or human immunodeficiency virus antibody (HIV) at screening.
18 Years
80 Years
ALL
Yes
Sponsors
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Toray Industries, Inc
INDUSTRY
Responsible Party
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Locations
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London
London, , United Kingdom
Countries
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Other Identifiers
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750P1C01
Identifier Type: -
Identifier Source: org_study_id
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