Clinical trial NCT02106780: A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707
Official title: An Open Label Study to Evaluate the Pharmacokinetics of ASP1707 After a Single Oral Dose of 14C-labeled ASP1707 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of ASP1707
Keywords: Phase 1
Healthy subjects
Excretion
14C-labeled ASP1707
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-04-08
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: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf)
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in whole blood measured by Area under the plasma concentration - time curve to the last quantifiable concentration (AUClast)
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in whole blood measured by Maximum concentration (Cmax)
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in whole blood measured by Time to Attain Cmax (tmax)
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in whole blood measured by Apparent total body clearance (CL/F)
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F)
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in plasma measured by AUCinf
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in plasma measured by AUClast
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in plasma measured by Cmax
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in plasma measured by tmax
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in plasma measured by t1/2
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in plasma measured by CL/F
timeFrame: Day -1 until at least Day 7
measure: Radioactivity in plasma measured by Vz/F
timeFrame: Day -1 until at least Day 7
measure: Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC)
timeFrame: Day -1 until at least Day 7
measure: Excretion rate and cumulative excretion of radioactivity in urine
timeFrame: Day -1 until at least Day 7
measure: Excretion rate and cumulative excretion of radioactivity in feces
timeFrame: Day -1 until at least Day 7
measure: Total cumulative excretion of radioactivity in urine and feces
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in plasma measured by AUCinf
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in plasma measured by AUClast
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in plasma measured by Cmax
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in plasma measured by tmax
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in plasma measured by t1/2
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in plasma measured by CL/F
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in plasma measured by Vz/F
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf)
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast)
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in urine measured by Renal Clearance (CLR)
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%)
timeFrame: Day -1 until at least Day 7
measure: ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %)
timeFrame: Day -1 until at least Day 7
Secondary outcomes:
measure: Profiling of metabolites in plasma, urine and feces
timeFrame: Day -1 until at least Day 7
measure: Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination
timeFrame: Screening to ESV (up to Day 40)
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance CRU Ltd.
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References: