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

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ClinicalTrials.gov Identifier: NCT02805244
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Anemia of Chronic Kidney Disease Drug: JTZ-951, 14C-JTZ-951 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : June 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Radioactivity concentration in urine, feces and dialysate [ Time Frame: maximum 20 days ]
  2. Radioactivity concentration in whole blood and plasma [ Time Frame: maximum 20 days ]
  3. Plasma concentrations of JTZ-951 and its metabolite [ Time Frame: maximum 20 days ]
  4. Cmax (maximum concentration) [ Time Frame: maximum 20 days ]
  5. tmax (time to reach maximum concentration) [ Time Frame: maximum 20 days ]
  6. AUC (area under the concentration-time curve) [ Time Frame: maximum 20 days ]
  7. t1/2 (elimination half-life) [ Time Frame: maximum 20 days ]
  8. Number of adverse events [ Time Frame: maximum 20 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805244


Locations
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United States, Minnesota
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Akros Pharma Inc.
More Information
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Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT02805244    
Other Study ID Numbers: AZ951-U-15-010
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Keywords provided by Akros Pharma Inc.:
JTZ-951
Pharmacokinetics
14C-JTZ-951
Mass balance
Time course
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency