Clinical trial NCT02046798: A Study to Assess the Pharmacokinetics, Metabolism and Excretion Routes of ASP3652 in Man, After Administration of 14C Radio Labeled ASP3652
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Pharmacokinetics of ASP3652
Keywords: Pharmacokinetics
ASP3652
14C radio-labeled
Phase 1
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total radioactivity in plasma
timeFrame: Days 1 to 6 and up to Day 9
measure: Total radioactivity in whole blood
timeFrame: Days 1 to 6 and up to Day 9
measure: Radioactivity ratio of plasma / blood
timeFrame: Days 1 to 6 and up to Day 9
measure: Radioactivity excretion in urine
timeFrame: Urine: Days 1-6 and up to Day 25
measure: Radioactivity excretion in feces
timeFrame: Days 1-6 and up to Day 25
measure: Radioactivity excretion in urine and feces
timeFrame: Urine: Days 1-6 and up to Day 25
measure: ASP3652 in plasma
timeFrame: Days 1 to 6 and up to Day 9
measure: ASP3652 in urine
timeFrame: Days 1-6 and up to Day 25
measure: Ratio ASP3652 to 14C-radioactivity for AUCinf
timeFrame: Days 1 to 6 and up to Day 9
Secondary outcomes:
measure: Safety and tolerability after a single dose
timeFrame: Screening (Day 22 to Day 2) to End of Study Visit (7 to 14 days after (early) discharge)
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit (CRU) Ltd.
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References: