NCT02805244

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

June 15, 2016

Last Update Submit

November 28, 2016

Conditions

Anemia of Chronic Kidney Disease

Keywords

JTZ-951Pharmacokinetics14C-JTZ-951Mass balanceTime course

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

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

JTZ-951, 14C-JTZ-951DRUG
JTZ-951, 14C-JTZ-951

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Minneapolis, Minnesota, United States

Location

MeSH Terms

Interventions

enarodustat

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

US(1)