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

NCT ID: NCT03346330

Last Updated: 2018-12-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2018-08-31

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.

Detailed Description

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Conditions

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Healthy, Peripheral Neuropathic Pain

Keywords

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Chronic pain Neuropathic pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TRK-750, single and multiple doses

Group Type EXPERIMENTAL

TRK-750

Intervention Type DRUG

TRK-750 capsule

Placebo, single and multiple doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule

Interventions

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TRK-750

TRK-750 capsule

Intervention Type DRUG

Placebo

Placebo capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female volunteers
* 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 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toray Industries, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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750P1C01

Identifier Type: -

Identifier Source: org_study_id