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

Primary Purpose

Healthy, Peripheral Neuropathic Pain

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

TRK-750

Placebo

About this trial

This is an interventional treatment trial for Healthy, Peripheral Neuropathic Pain focused on measuring Chronic pain, Neuropathic pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRK-750, single and multiple doses

Placebo, single and multiple doses

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03

Proportion of subjects with clinically significant changes in laboratory safety tests

Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram

Proportion of subjects with clinically significant changes in electrocardiogram time intervals

Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg)

Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg)

Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm)

Proportion of subjects with clinically significant changes in vital signs:body temperature(°C)

Secondary Outcome Measures

Full Information

NCT ID

NCT03346330

First Posted

November 8, 2017

Last Updated

December 17, 2018

Sponsor

Toray Industries, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03346330

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

November 21, 2017 (Actual)

Primary Completion Date

August 31, 2018 (Actual)

Study Completion Date

August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Toray Industries, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Peripheral Neuropathic Pain

Keywords

Chronic pain, Neuropathic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRK-750, single and multiple doses

Arm Type

Experimental

Arm Title

Placebo, single and multiple doses

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TRK-750

Intervention Description

TRK-750 capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsule

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03

Time Frame