CompletedNCT02805244Updated Nov 29, 2016

Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis

A Phase 1 interventional study of JTZ-951, 14C-JTZ-951 in Anemia of Chronic Kidney Disease, sponsored by Akros Pharma Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by Akros Pharma Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 6
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: Male

Study 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).

Conditions studied

Anemia of Chronic Kidney Disease

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Keywords

JTZ-951
Pharmacokinetics
14C-JTZ-951
Mass balance
Time course

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 6 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Akros Pharma Inc. is the lead sponsor of 25 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 6 participants (actual)

Study arms

Experimental
JTZ-951, 14C-JTZ-951
Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951
Drug: JTZ-951, 14C-JTZ-951

Interventions

DrugJTZ-951, 14C-JTZ-951

What researchers measure

Primary outcomes

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

Study locations

1 site

Minneapolis, Minnesota, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02805244
Lead sponsor: Akros Pharma Inc.
Responsible party: Sponsor
First posted: Jun 17, 2016
Start date: Jun 2016
Primary completion: Sep 2016
Completion: Sep 2016
Last update: Nov 29, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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