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Completed

NCT Number: NCT02805244

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

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Key information

Conditions

Anemia of Chronic Kidney Disease

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Minneapolis, Minnesota, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JTZ-951, 14C-JTZ-951

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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