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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03346330

Enrollment

105

Registered

2017-11-17

Start date

2017-11-21

Completion date

2018-08-31

Last updated

2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Peripheral Neuropathic Pain

Keywords

Chronic pain, Neuropathic pain

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.

Interventions

DRUGTRK-750

TRK-750 capsule

DRUGPlacebo

Placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026