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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02805244
Other study ID # AZ951-U-15-010
Secondary ID
Status Completed
Phase Phase 1
First received June 15, 2016
Last updated November 28, 2016
Start date June 2016
Est. completion date September 2016

Study information

Verified date November 2016
Source Akros Pharma Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
JTZ-951, 14C-JTZ-951


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radioactivity concentration in urine, feces and dialysate maximum 20 days No
Primary Radioactivity concentration in whole blood and plasma maximum 20 days No
Primary Plasma concentrations of JTZ-951 and its metabolite maximum 20 days No
Primary Cmax (maximum concentration) maximum 20 days No
Primary tmax (time to reach maximum concentration) maximum 20 days No
Primary AUC (area under the concentration-time curve) maximum 20 days No
Primary t1/2 (elimination half-life) maximum 20 days No
Primary Number of adverse events maximum 20 days Yes
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