Anemia of Chronic Kidney DiseasePhase 1NCT02805244
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
A Phase 1 study testing JTZ-951, 14C-JTZ-951 in people with Anemia of Chronic Kidney Disease, run by Shionogi Inc. at 1 site in United States.
Trial summary
A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- JTZ-951, 14C-JTZ-951
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with end stage renal disease on hemodialysis
- Post-dialysis body weight >45.0 kg
- BMI between 18.0 and 40.0 kg/m2 (inclusive)
Who cannot join
- Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.0 × upper limit of normal (ULN), or total bilirubin >1.5 × ULN at the Screening Visit
- Subjects who have hepatobiliary disease or condition (such as biliary cirrhosis)
- Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody
- Subjects with known history of liver failure or liver surgery
- Subjects with a history or current clinically significant chronic or acute blood loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single Dose, Mass Balance Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of 14C-JTZ-951 in Male Subjects With End-stage Renal Disease Receiving Hemodialysis
A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- JTZ-951, 14C-JTZ-951
- Keywords
- JTZ-951, Pharmacokinetics, 14C-JTZ-951, Mass balance, Time course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTZ-951, 14C-JTZ-951Drug
| Study group | Role | What they receive |
|---|---|---|
| JTZ-951, 14C-JTZ-951 | Experimental | Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951 Receives: Drug: JTZ-951, 14C-JTZ-951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity concentration in urine, feces and dialysate
Measured: maximum 20 days
Radioactivity concentration in whole blood and plasma
Measured: maximum 20 days
Plasma concentrations of JTZ-951 and its metabolite
Measured: maximum 20 days
Cmax (maximum concentration)
Measured: maximum 20 days
tmax (time to reach maximum concentration)
Measured: maximum 20 days
AUC (area under the concentration-time curve)
Measured: maximum 20 days
t1/2 (elimination half-life)
Measured: maximum 20 days
Number of adverse events
Measured: maximum 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805244
- Sponsor's protocol ID
- AZ951-U-15-010
- Status last verified
- Nov 2016
- First submitted
- 15 Jun 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Dose, Mass Balance Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of 14C-JTZ-951 in Male Subjects With End-stage Renal Disease Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT02805244
- Acronym / sponsor ID
- AZ951-U-15-010
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- JTZ-951, Pharmacokinetics, 14C-JTZ-951, Mass balance, Time course
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Jun 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.
A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JTZ-951, 14C-JTZ-951 | Experimental | Drug: JTZ-951, 14C-JTZ-951Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with end stage renal disease on hemodialysis
- Post-dialysis body weight >45.0 kg
- BMI between 18.0 and 40.0 kg/m2 (inclusive)
Key exclusion criteria (5 listed)
- Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.0 × upper limit of normal (ULN), or total bilirubin >1.5 × ULN at the Screening Visit
- Subjects who have hepatobiliary disease or condition (such as biliary cirrhosis)
- Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody
- Subjects with known history of liver failure or liver surgery
- Subjects with a history or current clinically significant chronic or acute blood loss
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 |
|---|---|---|
| JTZ-951, 14C-JTZ-951 | Drug | JTZ-951, 14C-JTZ-951 |
Primary outcome
Radioactivity concentration in urine, feces and dialysate
Time frame: maximum 20 days
Radioactivity concentration in whole blood and plasma
Time frame: maximum 20 days
Plasma concentrations of JTZ-951 and its metabolite
Time frame: maximum 20 days
Cmax (maximum concentration)
Time frame: maximum 20 days
tmax (time to reach maximum concentration)
Time frame: maximum 20 days
AUC (area under the concentration-time curve)
Time frame: maximum 20 days
t1/2 (elimination half-life)
Time frame: maximum 20 days
Number of adverse events
Time frame: maximum 20 days
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 29 Nov 2016.
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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.
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 JTZ-951, 14C-JTZ-951 in people with Anemia of Chronic Kidney Disease, run by Shionogi 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 5 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 29 Nov 2016. 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?
Radioactivity concentration in urine, feces and dialysate (time frame: maximum 20 days). 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 29 Nov 2016.