A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707
- Conditions
- Pharmacokinetics of ASP1707
- Interventions
- Drug: 14C-labeled ASP1707
- Registration Number
- NCT02106780
- Lead Sponsor
- Astellas Pharma Europe B.V.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1: ASP1707 14C-labeled ASP1707 -
- Primary Outcome Measures
Name Time Method Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2) 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) Day -1 until at least Day 7 Radioactivity in whole blood measured by Maximum concentration (Cmax) Day -1 until at least Day 7 Radioactivity in whole blood measured by Apparent total body clearance (CL/F) Day -1 until at least Day 7 Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F) Day -1 until at least Day 7 Radioactivity in plasma measured by AUCinf Day -1 until at least Day 7 Radioactivity in plasma measured by AUClast Day -1 until at least Day 7 Radioactivity in plasma measured by Cmax Day -1 until at least Day 7 Radioactivity in plasma measured by tmax Day -1 until at least Day 7 Radioactivity in plasma measured by t1/2 Day -1 until at least Day 7 Radioactivity in plasma measured by CL/F Day -1 until at least Day 7 Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf) Day -1 until at least Day 7 Radioactivity in whole blood measured by Time to Attain Cmax (tmax) Day -1 until at least Day 7 Radioactivity in plasma measured by Vz/F Day -1 until at least Day 7 Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC) Day -1 until at least Day 7 Excretion rate and cumulative excretion of radioactivity in urine Day -1 until at least Day 7 Excretion rate and cumulative excretion of radioactivity in feces Day -1 until at least Day 7 Total cumulative excretion of radioactivity in urine and feces Day -1 until at least Day 7 ASP1707 in plasma measured by AUCinf Day -1 until at least Day 7 ASP1707 in plasma measured by AUClast Day -1 until at least Day 7 ASP1707 in plasma measured by Cmax Day -1 until at least Day 7 ASP1707 in plasma measured by tmax Day -1 until at least Day 7 ASP1707 in plasma measured by t1/2 Day -1 until at least Day 7 ASP1707 in plasma measured by CL/F Day -1 until at least Day 7 ASP1707 in plasma measured by Vz/F Day -1 until at least Day 7 ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf) Day -1 until at least Day 7 ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast) Day -1 until at least Day 7 ASP1707 in urine measured by Renal Clearance (CLR) Day -1 until at least Day 7 ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%) Day -1 until at least Day 7 ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %) Day -1 until at least Day 7
- Secondary Outcome Measures
Name Time Method Profiling of metabolites in plasma, urine and feces Day -1 until at least Day 7 This will be done separately from this study and will be reported in a separate report
Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination Screening to ESV (up to Day 40)
Trial Locations
- Locations (1)
Covance CRU Ltd.
🇬🇧Leeds, United Kingdom