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

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ClinicalTrials.gov Identifier: NCT03346330
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy, Peripheral Neuropathic Pain Drug: TRK-750 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346330


Locations
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United Kingdom
London
London, United Kingdom
Sponsors and Collaborators
Toray Industries, Inc
More Information
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Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT03346330    
Other Study ID Numbers: 750P1C01
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toray Industries, Inc:
Chronic pain
Neuropathic pain
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations