Mass Balance Study of JTZ-951 in Subjects With End-stage... | NCT02805244

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

NCT02805244

Sponsor

Akros Pharma Inc.

Status

Completed

Last Update Posted

Nov 29, 2016Estimated

Enrollment

6Actual

Phase

Phase 1

Conditions

Anemia of Chronic Kidney Disease

Interventions

JTZ-951, 14C-JTZ-951

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Jun 15, 2016

First Submission Date that Met QC Criteria

Jun 15, 2016

First Posted Date

Jun 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2016

Last Update Posted Date

Nov 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JTZ-951, 14C-JTZ-951	Experimental	Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951	Drug: JTZ-951, 14C-JTZ-951

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JTZ-951, 14C-JTZ-951	Drug		JTZ-951, 14C-JTZ-951

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radioactivity concentration in urine, feces and dialysate		maximum 20 days
Radioactivity concentration in whole blood and plasma		maximum 20 days
Plasma concentrations of JTZ-951 and its metabolite		maximum 20 days
Cmax (maximum concentration)		maximum 20 days
tmax (time to reach maximum concentration)		maximum 20 days
AUC (area under the concentration-time curve)		maximum 20 days
t1/2 (elimination half-life)		maximum 20 days
Number of adverse events		maximum 20 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Minneapolis	Minnesota		United States

Intervention Browse Module

MeSH Terms

ID	Term
C000656654	enarodustat

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided