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

April 4, 2014 updated by: Astellas Pharma Europe B.V.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1: ASP1707
Drug: 14C-labeled ASP1707
oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf)
Time Frame: Day -1 until at least Day 7
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)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in whole blood measured by Maximum concentration (Cmax)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in whole blood measured by Time to Attain Cmax (tmax)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent total body clearance (CL/F)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in plasma measured by AUCinf
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in plasma measured by AUClast
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in plasma measured by Cmax
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in plasma measured by tmax
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in plasma measured by t1/2
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in plasma measured by CL/F
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity in plasma measured by Vz/F
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in urine
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in feces
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
Total cumulative excretion of radioactivity in urine and feces
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in plasma measured by AUCinf
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in plasma measured by AUClast
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in plasma measured by Cmax
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in plasma measured by tmax
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in plasma measured by t1/2
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in plasma measured by CL/F
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in plasma measured by Vz/F
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in urine measured by Renal Clearance (CLR)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %)
Time Frame: Day -1 until at least Day 7
Day -1 until at least Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Profiling of metabolites in plasma, urine and feces
Time Frame: Day -1 until at least Day 7
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
Time Frame: Screening to ESV (up to Day 40)
Screening to ESV (up to Day 40)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Europe B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1707-CL-0021
  • 2011-001701-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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