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Healthy VolunteersPhase 1NCT03746067

Safety, Tolerability and Pharmacokinetics of Single Doses of TS-134 in Healthy Volunteers

A Phase 1 study testing TS-134 in people with Healthy Volunteers, run by Taisho Pharmaceutical R&D Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be evaluated. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
TS-134
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteUnited States
Study dates
21 Aug 2015to 13 Jan 2016
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male and female participants between 18 and 55 years of age
  • Body weight greater than or equal to 45 kg
  • Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m^2

Who cannot join

  • Female participants who are pregnant, intend to become pregnant, or are breastfeeding
  • Clinically significant abnormal physical examination, 12-lead electrocardiogram (ECG) OR cardiac telemetry prior to dosing.
  • Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, locomotor, immunologic, ophthalmologic, metabolic or oncological disease.
  • History or presence of psychiatric or neurologic disease or condition
  • History of alcohol or drug abuse
  • Any participant who currently uses or has used tobacco or tobacco-containing products for at least one month prior to screening
  • Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or are unwilling to avoid strenuous exercise at any time throughout the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PAREXEL - Early Phase Clinical Unit-Los Angeles

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Effects of Food on the Absorption of TS-134 Administered Orally to Healthy Male and Female Subjects

This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be evaluated.

Being tested
TS-134, Placebo
Keywords
TS-134, CSF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TS-134Drug

    5 mg, 10 mg, or 20 mg oral solution

  • PlaceboDrug

    Matched Placebo oral solution

Study groups in NCT03746067
Study groupRoleWhat they receive
TS-134ExperimentalHealthy adult subjects will be prospectively assigned to 1 of 4 cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio (6 active + 2 placebo) per cohort to receive TS-134 or placebo as a single oral dose solution. All cohorts will be dosed in a fasted state except for the 2nd and 4th (food effect) cohorts, which will be dosed first in a fasted state, and then in a fed state, in a single crossover design conducted with a washout between two periods. In the 3rd (CSF) cohort, 8 subjects will receive one dose level of TS-134 as a single-blind dosing assignment; there will be no placebo dosing.
Receives: Drug: TS-134
PlaceboPlacebo comparatorHealthy adult subjects will be prospectively assigned to 1 of 4 cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio (6 active + 2 placebo) per cohort to receive TS-134 or placebo as a single oral dose solution. All cohorts will be dosed in a fasted state except for the 2nd and 4th (food effect) cohorts, which will be dosed first in a fasted state, and then in a fed state, in a single crossover design conducted with a washout between two periods. In the 3rd (CSF) cohort, the 8 subjects will receive one dose level of TS-134 as a single-blind dosing assignment; there will be no placebo dosing.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Adverse Events

    Measured: Day 1 to Day 7

  2. TS-134 Plasma Pharmacokinetic Profile - Cmax

    Maximum plasma concentration

    Measured: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

  3. TS-134 Plasma Pharmacokinetic Profile - AUC(0-last)

    Area under the concentration vs. time curve from time zero to last measurable concentration

    Measured: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

  4. TS-134 Plasma Pharmacokinetic Profile - tmax

    Time to maximum plasma concentration

    Measured: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

  5. TS-134 Plasma Pharmacokinetic Profile - t1/2

    Apparent terminal elimination half-life

    Measured: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

  6. TS-134 Plasma Pharmacokinetic Profile - CL/F

    Apparent clearance following oral administration

    Measured: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

  7. TS-134 Plasma Pharmacokinetic Profile - Vd/F

    Apparent volumes of distribution following oral administration

    Measured: Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

Secondary outcomes (6)

  1. TS-134 Cerebral Spinal Fluid (CSF) Pharmacokinetic Profile - Cmax

    Maximum CSF concentration

    Measured: Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose

  2. TS-134 CSF Pharmacokinetic Profile - AUC(0-last)

    Area under the CSF concentration vs. time curve from time zero to last measurable concentration

    Measured: Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose

  3. TS-134 CSF Pharmacokinetic Profile - tmax

    Time to maximum CSF concentration

    Measured: Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose

  4. TS-134 CSF Pharmacokinetic Profile - t1/2

    Apparent terminal elimination half-life (CSF)

    Measured: Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose

  5. TS-134 CSF Pharmacokinetic Profile - CL/F

    Apparent clearance (CSF) following oral administration

    Measured: Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose

  6. TS-134 CSF Pharmacokinetic Profile - Vd/F

    Apparent volumes of distribution (CSF) following oral administration

    Measured: Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2018
  2. Study start21 Aug 2015
  3. Primary completion13 Jan 2016
  4. Study completion13 Jan 2016

Resources

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03746067
Sponsor's protocol ID
TS134-US101
Status last verified
Nov 2018
First submitted
18 Oct 2018
Last updated
19 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TS-134 in people with Healthy Volunteers, run by Taisho Pharmaceutical R&D Inc. at 1 site in United States.

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 3 inclusion and 7 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 Nov 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 States. 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 and severity of Adverse Events (time frame: Day 1 to Day 7). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03746067.

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 Nov 2018.

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