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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy, Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: Placebo; Drug: TRK-750

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRK-750, single and multiple doses	Drug: TRK-750; TRK-750 capsule
Placebo Comparator: Placebo, single and multiple doses	Drug: Placebo; Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03	Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in laboratory safety tests	Up to 10-14days after last dose
Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram	Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in electrocardiogram time intervals	Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg)	Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg)	Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm)	Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:body temperature(°C)	Up to 10-14days after last dose

Collaborators and Investigators

• Sponsor: Toray Industries, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Chronic pain; Neuropathic pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: 750P1C01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No