HealthyPhase 1NCT02693197
PK Study of T-817 in Subjects With Hepatic Impairment
A Phase 1 study testing T-817MA in people with Healthy and Hepatic Impairment, run by FUJIFILM Toyama Chemical Co., Ltd. at 2 sites in United States.
Trial summary
The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatic Impairment
- What is being tested?
- T-817MA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Aug 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For subjects with mild, moderate or severe hepatic impairment
- Adult male or female, 18 - 75 years of age
- Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
- Have mild, moderate or severe defined by Child-Pugh classification hepatic impairment
- For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
- Female subjects who are pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida
Orlando Clinical Research Center
Orlando, Florida
About this study
Official title: A Phase 1, Two-Part, Open-Label, Parallel-Cohort, Single-Dose Study to Determine the Pharmacokinetics of T-817MA in Adult Subjects With Hepatic Impairment and in Healthy Adult Subjects
The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.
The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.
- Conditions
- Healthy, Hepatic Impairment
- Being tested
- T-817MA
- Keywords
- Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-817MADrug
A single oral dose of 448 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:T-817MA | Experimental | Mild hepatic impairment subjects Receives: Drug: T-817MA |
| Cohort 2:T-817MA | Experimental | Healthy subjects matched to subjects in Cohort 1 Receives: Drug: T-817MA |
| Cohort 3:T-817MA | Experimental | Moderate hepatic impairment subjects Receives: Drug: T-817MA |
| Cohort 4:T-817MA | Experimental | Healthy subjects matched to subjects in Cohort 3 Receives: Drug: T-817MA |
| Cohort 5 :T-817MA | Experimental | Severe hepatic impairment subjects Receives: Drug: T-817MA |
| Cohort 6:T-817MA | Experimental | Healthy subjects matched to subjects in Cohort 5 Receives: Drug: T-817MA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations
Measured: 8 days
Area under the plasma concentration time curve (AUC)
Measured: 8 days
Maximum observed plasma concentration (Cmax)
Measured: 8 days
Time to reach the maximum observed plasma concentration (tmax)
Measured: 8 days
Apparent terminal elimination rate constant
Measured: 8 days
Apparent terminal elimination half-life (t½)
Measured: 8 days
Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
Measured: 8 days
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
Measured: 8 days
Metabolite to parent ratio (MPR)
Measured: 8 days
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: 8days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Richard Preston, M.D., Principal investigator, University of MiamiThomas Marbury, M.D., Principal investigator, Orlando Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693197
- Sponsor's protocol ID
- T817MAUS113
- Status last verified
- May 2017
- First submitted
- 26 Jan 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part, Open-Label, Parallel-Cohort, Single-Dose Study to Determine the Pharmacokinetics of T-817MA in Adult Subjects With Hepatic Impairment and in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02693197
- Acronym / sponsor ID
- T817MAUS113
- Conditions
- Healthy, Hepatic Impairment
- Keywords
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- FUJIFILM Toyama Chemical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- 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.
The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.
The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1:T-817MA | Experimental | Drug: T-817MAMild hepatic impairment subjects |
| Cohort 2:T-817MA | Experimental | Drug: T-817MAHealthy subjects matched to subjects in Cohort 1 |
| Cohort 3:T-817MA | Experimental | Drug: T-817MAModerate hepatic impairment subjects |
| Cohort 4:T-817MA | Experimental | Drug: T-817MAHealthy subjects matched to subjects in Cohort 3 |
| Cohort 5 :T-817MA | Experimental | Drug: T-817MASevere hepatic impairment subjects |
| Cohort 6:T-817MA | Experimental | Drug: T-817MAHealthy subjects matched to subjects in Cohort 5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For subjects with mild, moderate or severe hepatic impairment
- Adult male or female, 18 - 75 years of age
- Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
- Have mild, moderate or severe defined by Child-Pugh classification hepatic impairment
- For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status
Key exclusion criteria (4 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
- Female subjects who are pregnant or lactating.
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 |
|---|---|---|
| T-817MAA single oral dose of 448 mg | Drug | Cohort 1:T-817MA, Cohort 2:T-817MA, Cohort 3:T-817MA, Cohort 4:T-817MA, Cohort 5 :T-817MA, Cohort 6:T-817MA |
Primary outcome
Plasma concentrations
Time frame: 8 days
Area under the plasma concentration time curve (AUC)
Time frame: 8 days
Maximum observed plasma concentration (Cmax)
Time frame: 8 days
Time to reach the maximum observed plasma concentration (tmax)
Time frame: 8 days
Apparent terminal elimination rate constant
Time frame: 8 days
Apparent terminal elimination half-life (t½)
Time frame: 8 days
Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
Time frame: 8 days
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
Time frame: 8 days
Metabolite to parent ratio (MPR)
Time frame: 8 days
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: 8days
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 24 Nov 2017.
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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.
Richard Preston, M.D. principal investigator
University of Miami
Thomas Marbury, M.D. principal investigator
Orlando Clinical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T-817MA in people with Healthy and Hepatic Impairment, run by FUJIFILM Toyama Chemical Co., Ltd. at 2 sites 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 5 inclusion and 4 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Plasma concentrations (time frame: 8 days). The study lists 9 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 24 Nov 2017.