Healthy VolunteersPhase 1NCT04464239
A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants
A Phase 1 study testing TS-142 in people with Healthy Volunteers, run by Taisho Pharmaceutical R&D Inc. at 1 site in United States.
Trial summary
This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers. This Phase I study is composed of two parts; Part A (Single Ascending Dose) and Part B (Repeated Dose). 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-142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 21 Jan 2021
- 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, inclusive
- Body weight ≥ 45 kg at screening and admission visits.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m^2 at screening visit.
Who cannot join
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and/or admission visits.
- Clinically significant abnormal physical examination (including neurological assessments), vital signs, or 12-lead ECGs at the screening and/or admission visits.
- QTcF >450 msec for male participants or QTcF >470 msec for female participants at the screening and/or admission visits.
- Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, neurological, immunologic, ophthalmologic, metabolic or oncological disease.
- History or present diagnosis of sleep disorders.
- Currently experiencing sleep disturbance related to postmenopausal symptoms at the screening and/or admission visits.
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- History or presence of suicidal behavior, defined as participants who have answered 'YES' to any of the C-SSRS suicidal behavior questions at the screening and/or admission visits.
- Positive urine screen for alcohol or controlled substances at the screening or admission visits.
- Recent history (within the previous 6 months) of alcohol or drug abuse.
- Regular alcohol consumption of > 2 units/day or 10 units/week during the last 3 months prior to screening. One unit is equivalent to 8 g of alcohol: a half pint (240 mL) of beer, a glass (125 mL) of wine, or 25 mL of spirits.
- Current use, or use of tobacco or tobacco-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) during the month prior to screening, or positive urine cotinine screen (>400 ng/mL) at the screening and/or admission visits.
- History of and/or current evidence of serologic positive results for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies 1 and 2.
- Donation of one or more units of blood, plasma (including platelet donations), or acute loss of an equivalent amount of blood within 60 days prior to screening visit (one unit= 450 mL).
- Exposure to any investigational product within 60 days prior to screening.
- Use of any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements within 14 days prior to administration of the study drug.
- Participants who regularly consume >500 mg of caffeine on a daily basis.
- Is known to be allergic to the study drug or any components of the study drug.
- Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or is unwilling to avoid strenuous exercise at any time throughout the study.
- Participants who work night shifts or need to work night shifts during the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 Administered Orally to Healthy Male and Female Participants
This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers. This Phase I study is composed of two parts; Part A (Single Ascending Dose) and Part B (Repeated Dose). The study employs a randomized, double-blind, placebo-controlled, parallel group design to evaluate the single and repeat-dose safety and pharmacokinetics of TS-142 in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- TS-142, TS-142 Placebo
- Keywords
- TS-142
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142Drug
TS-142 tablets
TS-142 PlaceboDrug
TS-142 matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1: TS-142 10 mg | Experimental | Single dose of TS-142 10 mg or placebo in a fasted condition Receives: Drug: TS-142; Drug: TS-142 Placebo |
| Part A: Cohort 2: TS-142 30 mg | Experimental | Single dose of TS-142 30 mg or placebo in a fasted condition. Receives: Drug: TS-142; Drug: TS-142 Placebo |
| Part B: Cohort 4: TS-142 20 mg | Experimental | Daily doses of 20 mg TS-142 or placebo for 7 days before bedtime. Receives: Drug: TS-142; Drug: TS-142 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events
Measured: Part A: Day 1 to Day 10; Part B: Day 1 to Day 16
TS-142 Plasma Pharmacokinetic Profile - Cmax
Maximum plasma concentration
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - Tmax
Time to maximum plasma concentration
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - AUC(0-∞)
Area Under the Concentration vs. Time Curve from Time Zero to Infinity
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - AUC(0-last)
Area Under the Concentration vs. Time Curve from Time Zero to Last Measurable Concentration
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - AUC(0-tau)
Area Under the Concentration vs. Time Curve over a Dosing Interval
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - %AUCex
Percentage of the area extrapolated for calculation of AUC(0-∞)
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - λz
Elimination rate constant
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - t1/2
Apparent terminal half-life
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - CL/F
Apparent oral clearance
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Plasma Pharmacokinetic Profile - Vd,z/F
Volumes of distribution
Measured: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
TS-142 Urine Pharmacokinetic Profile - Ae
Amount excreted in urine
Measured: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
TS-142 Urine Pharmacokinetic Profile - Fe%
Percent of dose excreted in urine
Measured: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
TS-142 Urine Pharmacokinetic Profile - CLr
Renal clearance
Measured: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start14 Sep 2020
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical R&D Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464239
- Sponsor's protocol ID
- TS142-US101
- Status last verified
- Feb 2021
- First submitted
- 6 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 Administered Orally to Healthy Male and Female Participants
- ClinicalTrials.gov ID
- NCT04464239
- Acronym / sponsor ID
- TS142-US101
- Conditions
- Healthy Volunteers
- Keywords
- TS-142
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 9 Jul 2020 (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 a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers. This Phase I study is composed of two parts; Part A (Single Ascending Dose) and Part B (Repeated Dose). The study employs a randomized, double-blind, placebo-controlled, parallel group design to evaluate the single and repeat-dose safety and pharmacokinetics of TS-142 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1: TS-142 10 mg | Experimental | Drug: TS-142, Drug: TS-142 PlaceboSingle dose of TS-142 10 mg or placebo in a fasted condition |
| Part A: Cohort 2: TS-142 30 mg | Experimental | Drug: TS-142, Drug: TS-142 PlaceboSingle dose of TS-142 30 mg or placebo in a fasted condition. |
| Part B: Cohort 4: TS-142 20 mg | Experimental | Drug: TS-142, Drug: TS-142 PlaceboDaily doses of 20 mg TS-142 or placebo for 7 days before bedtime. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult male and female participants between 18 and 55 years of age, inclusive
- Body weight ≥ 45 kg at screening and admission visits.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m^2 at screening visit.
Key exclusion criteria (19 listed)
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and/or admission visits.
- Clinically significant abnormal physical examination (including neurological assessments), vital signs, or 12-lead ECGs at the screening and/or admission visits.
- QTcF >450 msec for male participants or QTcF >470 msec for female participants at the screening and/or admission visits.
- Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, neurological, immunologic, ophthalmologic, metabolic or oncological disease.
- History or present diagnosis of sleep disorders.
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 |
|---|---|---|
| TS-142TS-142 tablets | Drug | Part A: Cohort 1: TS-142 10 mg, Part A: Cohort 2: TS-142 30 mg, Part B: Cohort 4: TS-142 20 mg |
| TS-142 PlaceboTS-142 matching placebo tablets | Drug | Part A: Cohort 1: TS-142 10 mg, Part A: Cohort 2: TS-142 30 mg, Part B: Cohort 4: TS-142 20 mg |
Primary outcome
Incidence and severity of Adverse Events
Time frame: Part A: Day 1 to Day 10; Part B: Day 1 to Day 16
TS-142 Plasma Pharmacokinetic Profile - Cmax
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Maximum plasma concentration
TS-142 Plasma Pharmacokinetic Profile - Tmax
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Time to maximum plasma concentration
TS-142 Plasma Pharmacokinetic Profile - AUC(0-∞)
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Area Under the Concentration vs. Time Curve from Time Zero to Infinity
TS-142 Plasma Pharmacokinetic Profile - AUC(0-last)
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Area Under the Concentration vs. Time Curve from Time Zero to Last Measurable Concentration
TS-142 Plasma Pharmacokinetic Profile - AUC(0-tau)
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Area Under the Concentration vs. Time Curve over a Dosing Interval
TS-142 Plasma Pharmacokinetic Profile - %AUCex
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Percentage of the area extrapolated for calculation of AUC(0-∞)
TS-142 Plasma Pharmacokinetic Profile - λz
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Elimination rate constant
TS-142 Plasma Pharmacokinetic Profile - t1/2
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Apparent terminal half-life
TS-142 Plasma Pharmacokinetic Profile - CL/F
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Apparent oral clearance
TS-142 Plasma Pharmacokinetic Profile - Vd,z/F
Time frame: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
Volumes of distribution
TS-142 Urine Pharmacokinetic Profile - Ae
Time frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
Amount excreted in urine
TS-142 Urine Pharmacokinetic Profile - Fe%
Time frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
Percent of dose excreted in urine
TS-142 Urine Pharmacokinetic Profile - CLr
Time frame: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
Renal clearance
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 10 Feb 2021.
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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.
Taisho Director study director
Taisho Pharmaceutical R&D Inc.
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 TS-142 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 19 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 10 Feb 2021. 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. 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: Part A: Day 1 to Day 10; Part B: Day 1 to Day 16). The study lists 14 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 10 Feb 2021.