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Clinical Trials/NCT01978587
NCT01978587CompletedPhase 1

A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Akros Pharma Inc.0 sites6 target enrollmentStarted: October 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
6
Primary Endpoint
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis

Study Overview

Brief Summary

The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
  • Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit

Exclusion Criteria

  • Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
  • Uncontrolled hypertension at the Screening Visit or Day -1

Arms & Interventions

Dose 1 JTZ-951

Experimental

Tablets, 1 dose on Day 1 before hemodialysis

Intervention: JTZ-951 (Drug)

Dose 2 JTZ-951

Experimental

Tablets, 1 dose on Day 8 after hemodialysis

Intervention: JTZ-951 (Drug)

Outcomes

Primary Outcomes

Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis

Time Frame: Days 1 to 4 and 8 to 11

AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis

Time Frame: Days 1 to 4 and 8 to 11

tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis

Time Frame: Days 1 to 4 and 8 to 11

t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis

Time Frame: Days 1 to 4 and 8 to 11

Secondary Outcomes

  • Vital signs and ECG (electrocardiogram)(14 days)
  • Number of subjects with adverse events(14 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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