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

NCT03346330 | Completed Phase 1

• 1 other identifier: 750P1C01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, Peripheral Neuropathic Pain

Keywords

Chronic pain; Neuropathic pain

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

TRK-750, single and multiple doses

EXPERIMENTAL

Drug: TRK-750

Placebo, single and multiple doses

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TRK-750 DRUG

TRK-750 capsule

TRK-750, single and multiple doses

Placebo DRUG

Placebo capsule

Placebo, single and multiple doses

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toray Industries, Inc: lead

Study Sites (1)

London

London, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 17, 2017
• Study Start: November 21, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

GB (1)