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

Healthy, Peripheral Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346330
• Other study ID #: 750P1C01
• Status: Completed
• Phase: Phase 1
• Start date: November 21, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2018
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy, Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• TRK-750
TRK-750 capsule
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United Kingdom	London	London

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

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