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Completed

NCT Number: NCT03346330

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

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.

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Key information

Conditions

Healthy, Peripheral Neuropathic Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

London

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

TRK-750

Drug

TRK-750 capsule

Placebo

Drug

Placebo capsule

Primary outcomes

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

    Time frame: Up to 10-14days after last dose

  2. Proportion of subjects with clinically significant changes in laboratory safety tests

    Time frame: Up to 10-14days after last dose

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

    Time frame: Up to 10-14days after last dose

  4. Proportion of subjects with clinically significant changes in electrocardiogram time intervals

    Time frame: Up to 10-14days after last dose

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

    Time frame: Up to 10-14days after last dose

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

    Time frame: Up to 10-14days after last dose

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

    Time frame: Up to 10-14days after last dose

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

    Time frame: Up to 10-14days after last dose

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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