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

Phase 1

Completed

• Conditions: Healthy, Peripheral Neuropathic Pain
• Interventions: Drug: Placebo; Drug: TRK-750

• Registration Number: NCT03346330
• Lead Sponsor: Toray Industries, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2017-11-21
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo, single and multiple doses	Placebo	-
TRK-750, single and multiple doses	TRK-750	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with clinically significant changes in laboratory safety tests	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
Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03	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 vital signs:systolic blood pressure(mmHg)	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:diastolic blood pressure(mmHg)	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

Trial Locations

Locations (1)

London; 🇬🇧 London, United Kingdom