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

Toray Industries

Status and phase: Completed; Phase 1

Conditions: Healthy, Peripheral Neuropathic Pain

Treatments: Drug: TRK-750; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03346330

750P1C01

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups, including a placebo group

TRK-750, single and multiple doses

Experimental group

Treatment:

Drug: TRK-750

Placebo, single and multiple doses

Placebo Comparator group

Treatment:

Drug: Placebo