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: March 18, 2014

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Akros Pharma Inc.
Enrollment: 6
Primary Endpoint: Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

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

Akros Pharma Inc.

Sponsor Class

Industry

Responsible Party

Sponsor

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