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Completed

NCT Number: NCT02046798

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

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.

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Key information

Conditions

Healthy Subjects Pharmacokinetics of ASP3652

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASP3652

Drug

oral

Primary outcomes

  1. Total radioactivity in plasma

    Time frame: Days 1 to 6 and up to Day 9

    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)

  2. Total radioactivity in whole blood

    Time frame: Days 1 to 6 and up to Day 9

    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)

  3. Radioactivity ratio of plasma / blood

    Time frame: Days 1 to 6 and up to Day 9

    ratio concentrations per time point and AUC

  4. Radioactivity excretion in urine

    Time frame: Urine: Days 1-6 and up to Day 25

    excretion rate and cumulative excretion

  5. Radioactivity excretion in feces

    Time frame: Days 1-6 and up to Day 25

    excretion rate and cumulative excretion

  6. Radioactivity excretion in urine and feces

    Time frame: Urine: Days 1-6 and up to Day 25

    excretion rate and cumulative excretion

  7. ASP3652 in plasma

    Time frame: Days 1 to 6 and up to Day 9

    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)

  8. ASP3652 in urine

    Time frame: Days 1-6 and up to Day 25

    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%)

  9. Ratio ASP3652 to 14C-radioactivity for AUCinf

    Time frame: Days 1 to 6 and up to Day 9

    area under the plasma concentration (AUC) - time curve from time zero to infinity (AUCinf)

Secondary outcomes

  1. Safety and tolerability after a single dose

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

    Vital signs, 12-lead ECG, safety laboratory tests, physical examination, occurrence of Adverse Events (AE)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2014
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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