Healthy, Peripheral Neuropathic PainPhase 1NCT03346330
Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750
A Phase 1 study testing TRK-750 in people with Healthy, Peripheral Neuropathic Pain, run by Toray Industries, Inc at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Peripheral Neuropathic Pain
- What is being tested?
- TRK-750
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Nov 2017to 31 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- TRK-750, Placebo
- Keywords
- Chronic pain, Neuropathic pain
- Medical subject headings
- Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-750Drug
TRK-750 capsule
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| TRK-750, single and multiple doses | Experimental | Not described Receives: Drug: TRK-750 |
| Placebo, single and multiple doses | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03
Measured: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in laboratory safety tests
Measured: Up to 10-14days after last dose
Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram
Measured: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in electrocardiogram time intervals
Measured: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg)
Measured: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg)
Measured: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm)
Measured: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:body temperature(°C)
Measured: Up to 10-14days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start21 Nov 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346330
- Sponsor's protocol ID
- 750P1C01
- Status last verified
- Dec 2018
- First submitted
- 8 Nov 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03346330
- Acronym / sponsor ID
- 750P1C01
- Conditions
- Healthy, Peripheral Neuropathic Pain
- Keywords
- Chronic pain, Neuropathic pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRK-750, single and multiple doses | Experimental | Drug: TRK-750 |
| Placebo, single and multiple doses | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female volunteers
- Female subjects who are either:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRK-750TRK-750 capsule | Drug | TRK-750, single and multiple doses |
| PlaceboPlacebo capsule | Drug | Placebo, single and multiple doses |
Primary outcome
Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03
Time frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in laboratory safety tests
Time frame: Up to 10-14days after last dose
Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram
Time frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in electrocardiogram time intervals
Time frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg)
Time frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg)
Time frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm)
Time frame: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:body temperature(°C)
Time frame: Up to 10-14days after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Related trials for Healthy, Peripheral Neuropathic Pain
RecruitingPhase 1
Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults
Neuropathic Pain
Not yet recruitingPhase 1
Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants
Healthy Male and Female Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRK-750 in people with Healthy, Peripheral Neuropathic Pain, run by Toray Industries, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03 (time frame: Up to 10-14days after last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.