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

Pharmacokinetics of ASP1707 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106780
• Other study ID #: 1707-CL-0021
• Secondary ID: 2011-001701-27
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2014
• Last updated: April 4, 2014
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: April 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pharmacokinetics of ASP1707

Intervention

Drug:
• 14C-labeled ASP1707
oral

Locations

Country	Name	City	State
United Kingdom	Covance CRU Ltd.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf)		Day -1 until at least Day 7	No
Primary	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	No
Primary	Radioactivity in whole blood measured by Maximum concentration (Cmax)		Day -1 until at least Day 7	No
Primary	Radioactivity in whole blood measured by Time to Attain Cmax (tmax)		Day -1 until at least Day 7	No
Primary	Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)		Day -1 until at least Day 7	No
Primary	Radioactivity in whole blood measured by Apparent total body clearance (CL/F)		Day -1 until at least Day 7	No
Primary	Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F)		Day -1 until at least Day 7	No
Primary	Radioactivity in plasma measured by AUCinf		Day -1 until at least Day 7	No
Primary	Radioactivity in plasma measured by AUClast		Day -1 until at least Day 7	No
Primary	Radioactivity in plasma measured by Cmax		Day -1 until at least Day 7	No
Primary	Radioactivity in plasma measured by tmax		Day -1 until at least Day 7	No
Primary	Radioactivity in plasma measured by t1/2		Day -1 until at least Day 7	No
Primary	Radioactivity in plasma measured by CL/F		Day -1 until at least Day 7	No
Primary	Radioactivity in plasma measured by Vz/F		Day -1 until at least Day 7	No
Primary	Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC)		Day -1 until at least Day 7	No
Primary	Excretion rate and cumulative excretion of radioactivity in urine		Day -1 until at least Day 7	No
Primary	Excretion rate and cumulative excretion of radioactivity in feces		Day -1 until at least Day 7	No
Primary	Total cumulative excretion of radioactivity in urine and feces		Day -1 until at least Day 7	No
Primary	ASP1707 in plasma measured by AUCinf		Day -1 until at least Day 7	No
Primary	ASP1707 in plasma measured by AUClast		Day -1 until at least Day 7	No
Primary	ASP1707 in plasma measured by Cmax		Day -1 until at least Day 7	No
Primary	ASP1707 in plasma measured by tmax		Day -1 until at least Day 7	No
Primary	ASP1707 in plasma measured by t1/2		Day -1 until at least Day 7	No
Primary	ASP1707 in plasma measured by CL/F		Day -1 until at least Day 7	No
Primary	ASP1707 in plasma measured by Vz/F		Day -1 until at least Day 7	No
Primary	ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf)		Day -1 until at least Day 7	No
Primary	ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast)		Day -1 until at least Day 7	No
Primary	ASP1707 in urine measured by Renal Clearance (CLR)		Day -1 until at least Day 7	No
Primary	ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%)		Day -1 until at least Day 7	No
Primary	ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %)		Day -1 until at least Day 7	No
Secondary	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	No
Secondary	Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination		Screening to ESV (up to Day 40)	No