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

NCT ID: NCT02805244

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Anemia of Chronic Kidney Disease

Keywords

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JTZ-951 Pharmacokinetics 14C-JTZ-951 Mass balance Time course

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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JTZ-951, 14C-JTZ-951

Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951

Group Type EXPERIMENTAL

JTZ-951, 14C-JTZ-951

Intervention Type DRUG

Interventions

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JTZ-951, 14C-JTZ-951

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Akros Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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AZ951-U-15-010

Identifier Type: -

Identifier Source: org_study_id