A Study to Assess the Pharmacokinetics, Metabolism and Excretion Routes of ASP3652 in Man, After Administration of 14C Radio Labeled ASP3652

Healthy Subjects Clinical Trial

Official title:

An Open Label Study to Evaluate the Pharmacokinetics of ASP3652 After a Single Oral Dose of 14C-labeled ASP3652 in Healthy Caucasian Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046798
• Other study ID #: 3652-CL-0003
• Secondary ID: 2011-004526-10
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2014
• Last updated: January 24, 2014
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: January 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

This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.

Description:

This is an open-label, one-period, single-dose study with 14C labeled ASP3652.

Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day -1.

On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652. Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least 120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected until 120 h after dosing.

The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject is white and of Caucasian origin.

• Regular defecation pattern (minimum once per day).

• Subject must agree to use a condom during sexual intercourse until 3 months after dosing. In addition to using a condom, subjects must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.

Exclusion Criteria:

• Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.

• Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.

• 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.

Study Design

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

Related Conditions & MeSH terms

• Healthy Subjects
• Pharmacokinetics of ASP3652

Intervention

Drug:
• ASP3652
oral

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit (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	Total radioactivity in plasma	area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)	Days 1 to 6 and up to Day 9	No
Primary	Total radioactivity in whole blood	area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf), area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), maximum concentration (Cmax), time to attain Cmax (tmax), apparent terminal elimination half-life (t½)	Days 1 to 6 and up to Day 9	No
Primary	Radioactivity ratio of plasma / blood	ratio concentrations per time point and AUC	Days 1 to 6 and up to Day 9	No
Primary	Radioactivity excretion in urine	excretion rate and cumulative excretion	Urine: Days 1-6 and up to Day 25	No
Primary	Radioactivity excretion in feces	excretion rate and cumulative excretion	Days 1-6 and up to Day 25	No
Primary	Radioactivity excretion in urine and feces	excretion rate and cumulative excretion	Urine: Days 1-6 and up to Day 25	No
Primary	ASP3652 in plasma	AUCinf, AUClast, Cmax, tmax, t1/2, apparent clearance after oral administration at steady state (CL/F), volume of terminal phase distribution at steady state (Vz/F)	Days 1 to 6 and up to Day 9	No
Primary	ASP3652 in urine	cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf), cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast), renal clearance of the drug from plasma (CLR), percentage of unchanged drug excreted into the urine from time zero to infinity after single dose % of dose excreted (Aeinf%), percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)	Days 1-6 and up to Day 25	No
Primary	Ratio ASP3652 to 14C-radioactivity for AUCinf	area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf)	Days 1 to 6 and up to Day 9	No
Secondary	Safety and tolerability after a single dose	Vital signs, 12-lead ECG, safety laboratory tests, physical examination, occurrence of Adverse Events (AE)	Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)	No