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

• Sponsor: Toray Industries, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03346330
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 11.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy, Peripheral Neuropathic Pain	Drug: TRK-750; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 21, 2017
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRK-750, single and multiple doses	Drug: TRK-750; TRK-750 capsule
Placebo Comparator: Placebo, single and multiple doses	Drug: Placebo; Placebo capsule

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03 [Up to 10-14days after last dose]

2. Proportion of subjects with clinically significant changes in laboratory safety tests [Up to 10-14days after last dose]

3. Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram [Up to 10-14days after last dose]

4. Proportion of subjects with clinically significant changes in electrocardiogram time intervals [Up to 10-14days after last dose]

5. Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg) [Up to 10-14days after last dose]

6. Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg) [Up to 10-14days after last dose]

7. Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm) [Up to 10-14days after last dose]

8. Proportion of subjects with clinically significant changes in vital signs:body temperature(°C) [Up to 10-14days after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London	London		United Kingdom

Sponsors and Collaborators

• Toray Industries, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Toray Industries, Inc
• ClinicalTrials.gov Identifier: NCT03346330
• Other Study ID Numbers: 750P1C01
• First Posted: Nov 17, 2017
• Last Update Posted: Dec 19, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Toray Industries, Inc: Chronic pain; Neuropathic pain
• Additional relevant MeSH terms: Neuralgia

Study Results

No Results Posted as of Dec 19, 2018