Clinical trial NCT03346330: Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy, Peripheral Neuropathic Pain
Keywords: Chronic pain
Neuropathic pain
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03
timeFrame: Up to 10-14days after last dose
measure: Proportion of subjects with clinically significant changes in laboratory safety tests
timeFrame: Up to 10-14days after last dose
measure: Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram
timeFrame: Up to 10-14days after last dose
measure: Proportion of subjects with clinically significant changes in electrocardiogram time intervals
timeFrame: Up to 10-14days after last dose
measure: Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg)
timeFrame: Up to 10-14days after last dose
measure: Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg)
timeFrame: Up to 10-14days after last dose
measure: Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm)
timeFrame: Up to 10-14days after last dose
measure: Proportion of subjects with clinically significant changes in vital signs:body temperature(°C)
timeFrame: Up to 10-14days after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London
Study officials:
References: