Patients with Mild or Moderate Hepatic ImpairmentPhase 1NCT05624944
A Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment
A Phase 1 study testing TS-142 5 mg in people with Patients with Mild or Moderate Hepatic Impairment, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients with Mild or Moderate Hepatic Impairment
- What is being tested?
- TS-142 5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteJapan
- Study dates
- 26 Dec 2022to 5 Dec 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- <Inclusion criteria for patients with hepatic impairment>
- Japanese male and female who are aged 18 to 75 years at the time of informed consent
- Patients with cirrhosis or chronic hepatic impairment
- Patients classified as Child-Pugh classification A (mild) or B (moderate) by the principal investigator or sub-investigator at the screening test Other protocol defined inclusion criteria could apply.
- <Inclusion criteria for subject with normal hepatic function>
- Japanese male and female who are aged 18 to 75 years at the time of informed consent
- Body Mass Index (BMI) between 18.5 and 35.0 at the screening test Other protocol defined inclusion criteria could apply.
Who cannot join
- <Exclusion criteria for patients with hepatic impairment>
- Patients who have a history of liver resection or liver transplant
- Patients with hepatic encephalopathy of grade II or higher
- Patients with epidermal growth factor receptor (eGFR) less than 45 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.
- <Exclusion criteria for subjects with normal hepatic function>
- Subjects who are judged to have any disease by the principal investigator or sub-investigator
- Subjects with eGFR less than 60 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment
This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment
- Being tested
- TS-142 5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142 5 mgDrug
Single-dose of 5 mg of TS-142
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment | Experimental | Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142 Receives: Drug: TS-142 5 mg |
| Moderate hepatic impairment | Experimental | Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142 Receives: Drug: TS-142 5 mg |
| Normal hepatic function | Experimental | Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142 Receives: Drug: TS-142 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration
Plasma concentration of unchanged form and its metabolite
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Maximum plasma concentration of unchanged form and its metabolite (Cmax)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Time to maximum plasma concentration of unchanged form and its metabolite (tmax)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Terminal elimination rate constant of unchanged form and its metabolite (λz)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Elimination half-life of unchanged form and its metabolite (t1/2)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Apparent total body clearance of unchanged form (CL/F)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Plasma unbound fraction of unchanged form and its metabolite (fu)
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Maximum plasma concentration adjusted by unbound fraction of unchanged form (Cmax(unbound))
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve extrapolated to infinity adjusted by unbound fraction of unchanged form (AUC(unbound))
Measured: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F)
Measured: Predose and up to 48 hours postdose
Secondary outcomes (1)
Incidence of adverse events
"Adverse event" refers to any unfavorable or unintended disease or symptom thereof (including abnormal laboratory tests values) occurring in a subject who has been administered an investigational product, whether or not there is a causal relationship with the investigational product.
Measured: From administration of investigational product through 10 days after administration of investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start26 Dec 2022
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with Mild or Moderate Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624944
- Sponsor's protocol ID
- TS142-303
- Status last verified
- Dec 2022
- First submitted
- 11 Nov 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment
- ClinicalTrials.gov ID
- NCT05624944
- Acronym / sponsor ID
- TS142-303
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 22 Nov 2022 (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 open-label pharmacokinetic study of TS-142 in patients with hepatic impairment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment | Experimental | Drug: TS-142 5 mgPatients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142 |
| Moderate hepatic impairment | Experimental | Drug: TS-142 5 mgPatients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142 |
| Normal hepatic function | Experimental | Drug: TS-142 5 mgSubjects with normal hepatic function will receive a single-dose of 5 mg of TS-142 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- <Inclusion criteria for patients with hepatic impairment>
- Japanese male and female who are aged 18 to 75 years at the time of informed consent
- Patients with cirrhosis or chronic hepatic impairment
- Patients classified as Child-Pugh classification A (mild) or B (moderate) by the principal investigator or sub-investigator at the screening test Other protocol defined inclusion criteria could apply.
- <Inclusion criteria for subject with normal hepatic function>
Key exclusion criteria (7 listed)
- <Exclusion criteria for patients with hepatic impairment>
- Patients who have a history of liver resection or liver transplant
- Patients with hepatic encephalopathy of grade II or higher
- Patients with epidermal growth factor receptor (eGFR) less than 45 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.
- <Exclusion criteria for subjects with normal hepatic function>
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-142 5 mgSingle-dose of 5 mg of TS-142 | Drug | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function |
Primary outcome
Plasma concentration
Time frame: Predose and up to 48 hours postdose
Plasma concentration of unchanged form and its metabolite
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Maximum plasma concentration of unchanged form and its metabolite (Cmax)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Time to maximum plasma concentration of unchanged form and its metabolite (tmax)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Terminal elimination rate constant of unchanged form and its metabolite (λz)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Elimination half-life of unchanged form and its metabolite (t1/2)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Apparent total body clearance of unchanged form (CL/F)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Plasma unbound fraction of unchanged form and its metabolite (fu)
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Maximum plasma concentration adjusted by unbound fraction of unchanged form (Cmax(unbound))
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Area under the plasma concentration-time curve extrapolated to infinity adjusted by unbound fraction of unchanged form (AUC(unbound))
Pharmacokinetic parameters
Time frame: Predose and up to 48 hours postdose
Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F)
1 secondary outcome
Incidence of adverse events
Time frame: From administration of investigational product through 10 days after administration of investigational product
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 28 Feb 2025.
- Individual participant dataSharing planned: No
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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 Co., Ltd.
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 5 mg in people with Patients with Mild or Moderate Hepatic Impairment, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
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 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 28 Feb 2025. 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 Japan. 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?
Plasma concentration (time frame: Predose and up to 48 hours postdose). The study lists 13 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 28 Feb 2025.