NCT02046798

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

January 24, 2014

Last Update Submit

January 24, 2014

Conditions

Healthy SubjectsPharmacokinetics of ASP3652

Keywords

PharmacokineticsASP365214C radio-labeledPhase 1

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • Radioactivity ratio of plasma / blood

    ratio concentrations per time point and AUC

    Days 1 to 6 and up to Day 9

  • Radioactivity excretion in urine

    excretion rate and cumulative excretion

    Urine: Days 1-6 and up to Day 25

  • Radioactivity excretion in feces

    excretion rate and cumulative excretion

    Days 1-6 and up to Day 25

  • Radioactivity excretion in urine and feces

    excretion rate and cumulative excretion

    Urine: Days 1-6 and up to Day 25

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Safety and tolerability after a single dose

    Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)

Study Arms (1)

14C labeled ASP3652

EXPERIMENTAL
Drug: ASP3652

Interventions

ASP3652DRUG

oral

14C labeled ASP3652

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

ASP3652

Study Officials

  • Central Contact

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

GB(1)