A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707

An Open Label Study to Evaluate the Pharmacokinetics of ASP1707 After a Single Oral Dose of 14C-labeled ASP1707 in Healthy Male Subjects

Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are collected until at least 144 hours after dosing.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics of ASP1707
• Intervention / Treatment: Drug: 14C-labeled ASP1707

Detailed Description

Subjects are admitted to the clinic on Day -1 and receive a single oral dose of 14C-labeled ASP1707 on Day 1. They remain in the clinic for 6 days and are discharged on Day 7 if sufficient recovery of administered radioactivity is achieved, or the total excretion (urine + feces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24-hour intervals. If these conditions are not met, the residential period may be prolonged for a maximum of 3 days. If after this time one of the conditions is still not met, subjects are requested to continue collecting their urine and/or feces at home for another 2 days. If after these additional 2 days one of the conditions is still not met, the condition of recovery of radioactivity is disregarded. Therefore only the total excretion condition is to be met by collecting 24-hour intervals for urine and feces once a week for up to 2 weeks. If the excretion condition is still not met after this time, no further samples are collected and the subject is discharged from the study.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance CRU Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subjects must be surgically sterilized and use condoms or must practice an effective contraceptive method to prevent pregnancies.
• Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
• Regular defecation pattern (minimum once per day).

Exclusion Criteria:

• Any of the liver function tests above the upper limit of normal.
• Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
• Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit.
• History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit.
• Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
• Positive serology test for Hepatitis B Surface Antigen (HBsAg), anti Hepatitis A Virus (HAV) Immunoglobulin M (IgM), anti Hepatitis C Virus (HCV) or anti Human Immunodeficiency Virus (HIV) 1+2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: ASP1707	Drug: 14C-labeled ASP1707; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf)	Day -1 until at least Day 7
Radioactivity in whole blood measured by Area under the plasma concentration - time curve to the last quantifiable concentration (AUClast)	Day -1 until at least Day 7
Radioactivity in whole blood measured by Maximum concentration (Cmax)	Day -1 until at least Day 7
Radioactivity in whole blood measured by Time to Attain Cmax (tmax)	Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)	Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent total body clearance (CL/F)	Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F)	Day -1 until at least Day 7
Radioactivity in plasma measured by AUCinf	Day -1 until at least Day 7
Radioactivity in plasma measured by AUClast	Day -1 until at least Day 7
Radioactivity in plasma measured by Cmax	Day -1 until at least Day 7
Radioactivity in plasma measured by tmax	Day -1 until at least Day 7
Radioactivity in plasma measured by t1/2	Day -1 until at least Day 7
Radioactivity in plasma measured by CL/F	Day -1 until at least Day 7
Radioactivity in plasma measured by Vz/F	Day -1 until at least Day 7
Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC)	Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in urine	Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in feces	Day -1 until at least Day 7
Total cumulative excretion of radioactivity in urine and feces	Day -1 until at least Day 7
ASP1707 in plasma measured by AUCinf	Day -1 until at least Day 7
ASP1707 in plasma measured by AUClast	Day -1 until at least Day 7
ASP1707 in plasma measured by Cmax	Day -1 until at least Day 7
ASP1707 in plasma measured by tmax	Day -1 until at least Day 7
ASP1707 in plasma measured by t1/2	Day -1 until at least Day 7
ASP1707 in plasma measured by CL/F	Day -1 until at least Day 7
ASP1707 in plasma measured by Vz/F	Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf)	Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast)	Day -1 until at least Day 7
ASP1707 in urine measured by Renal Clearance (CLR)	Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%)	Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %)	Day -1 until at least Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profiling of metabolites in plasma, urine and feces	This will be done separately from this study and will be reported in a separate report	Day -1 until at least Day 7
Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination		Screening to ESV (up to Day 40)

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe B.V.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): April 8, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Healthy subjects; Phase 1; Excretion; 14C-labeled ASP1707
• Other Study ID Numbers: 1707-CL-0021; 2011-001701-27 (EudraCT Number)