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Completed

NCT Number: NCT02581124

Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour after the administration of lapatinib.

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Key information

Conditions

Anemia of Chronic Kidney Disease

Age range

18 year–75 year

Sex eligibility

All sexes

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 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

Drug

Lapatinib

Drug

Primary outcomes

  1. Cmax (maximum concentration)

    Time frame: 10 days

  2. tmax (time to reach maximum concentration)

    Time frame: 10 days

  3. AUC (area under the concentration-time curve)

    Time frame: 10 days

  4. t1/2 (elimination half-life)

    Time frame: 10 days

  5. Number of adverse events

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Evaluate the Effect of Lapatinib, a BCRP Inhibitor, on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease Receiving Hemodialysis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Apr 28, 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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