Pharmacokinetics of ASP1707Phase 1NCT02106780
A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707
A Phase 1 study testing 14C-labeled ASP1707 in people with Pharmacokinetics of ASP1707, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of ASP1707
- What is being tested?
- 14C-labeled ASP1707
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pharmacokinetics of ASP1707
- Being tested
- 14C-labeled ASP1707
- Keywords
- Phase 1, Healthy subjects, Excretion, 14C-labeled ASP1707
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-labeled ASP1707Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1: ASP1707 | Experimental | Not described Receives: Drug: 14C-labeled ASP1707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf)
Measured: 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)
Measured: Day -1 until at least Day 7
Radioactivity in whole blood measured by Maximum concentration (Cmax)
Measured: Day -1 until at least Day 7
Radioactivity in whole blood measured by Time to Attain Cmax (tmax)
Measured: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)
Measured: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent total body clearance (CL/F)
Measured: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F)
Measured: Day -1 until at least Day 7
Radioactivity in plasma measured by AUCinf
Measured: Day -1 until at least Day 7
Radioactivity in plasma measured by AUClast
Measured: Day -1 until at least Day 7
Radioactivity in plasma measured by Cmax
Measured: Day -1 until at least Day 7
Radioactivity in plasma measured by tmax
Measured: Day -1 until at least Day 7
Radioactivity in plasma measured by t1/2
Measured: Day -1 until at least Day 7
Radioactivity in plasma measured by CL/F
Measured: Day -1 until at least Day 7
Radioactivity in plasma measured by Vz/F
Measured: Day -1 until at least Day 7
Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC)
Measured: Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in urine
Measured: Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in feces
Measured: Day -1 until at least Day 7
Total cumulative excretion of radioactivity in urine and feces
Measured: Day -1 until at least Day 7
ASP1707 in plasma measured by AUCinf
Measured: Day -1 until at least Day 7
ASP1707 in plasma measured by AUClast
Measured: Day -1 until at least Day 7
ASP1707 in plasma measured by Cmax
Measured: Day -1 until at least Day 7
ASP1707 in plasma measured by tmax
Measured: Day -1 until at least Day 7
ASP1707 in plasma measured by t1/2
Measured: Day -1 until at least Day 7
ASP1707 in plasma measured by CL/F
Measured: Day -1 until at least Day 7
ASP1707 in plasma measured by Vz/F
Measured: Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf)
Measured: Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast)
Measured: Day -1 until at least Day 7
ASP1707 in urine measured by Renal Clearance (CLR)
Measured: Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%)
Measured: Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %)
Measured: Day -1 until at least Day 7
Secondary outcomes (2)
Profiling of metabolites in plasma, urine and feces
This will be done separately from this study and will be reported in a separate report
Measured: Day -1 until at least Day 7
Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination
Measured: Screening to ESV (up to Day 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of ASP1707Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106780
- Sponsor's protocol ID
- 1707-CL-0021
- Other IDs
- 2011-001701-27
- Status last verified
- Apr 2014
- First submitted
- 4 Apr 2014
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02106780
- Acronym / sponsor ID
- 1707-CL-0021
- Conditions
- Pharmacokinetics of ASP1707
- Keywords
- Phase 1, Healthy subjects, Excretion, 14C-labeled ASP1707
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: ASP1707 | Experimental | Drug: 14C-labeled ASP1707 |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-labeled ASP1707oral | Drug | 1: ASP1707 |
Primary outcome
Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf)
Time frame: 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)
Time frame: Day -1 until at least Day 7
Radioactivity in whole blood measured by Maximum concentration (Cmax)
Time frame: Day -1 until at least Day 7
Radioactivity in whole blood measured by Time to Attain Cmax (tmax)
Time frame: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent Terminal Elimination Half-life (t1/2)
Time frame: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent total body clearance (CL/F)
Time frame: Day -1 until at least Day 7
Radioactivity in whole blood measured by Apparent volume of distribution (Vz/F)
Time frame: Day -1 until at least Day 7
Radioactivity in plasma measured by AUCinf
Time frame: Day -1 until at least Day 7
Radioactivity in plasma measured by AUClast
Time frame: Day -1 until at least Day 7
Radioactivity in plasma measured by Cmax
Time frame: Day -1 until at least Day 7
Radioactivity in plasma measured by tmax
Time frame: Day -1 until at least Day 7
Radioactivity in plasma measured by t1/2
Time frame: Day -1 until at least Day 7
Radioactivity in plasma measured by CL/F
Time frame: Day -1 until at least Day 7
Radioactivity in plasma measured by Vz/F
Time frame: Day -1 until at least Day 7
Radioactivity ratio of blood / plasma concentrations per time point and of Area under the plasma concentration (AUC)
Time frame: Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in urine
Time frame: Day -1 until at least Day 7
Excretion rate and cumulative excretion of radioactivity in feces
Time frame: Day -1 until at least Day 7
Total cumulative excretion of radioactivity in urine and feces
Time frame: Day -1 until at least Day 7
ASP1707 in plasma measured by AUCinf
Time frame: Day -1 until at least Day 7
ASP1707 in plasma measured by AUClast
Time frame: Day -1 until at least Day 7
ASP1707 in plasma measured by Cmax
Time frame: Day -1 until at least Day 7
ASP1707 in plasma measured by tmax
Time frame: Day -1 until at least Day 7
ASP1707 in plasma measured by t1/2
Time frame: Day -1 until at least Day 7
ASP1707 in plasma measured by CL/F
Time frame: Day -1 until at least Day 7
ASP1707 in plasma measured by Vz/F
Time frame: Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged extrapolated to time = infinity (Aeinf)
Time frame: Day -1 until at least Day 7
ASP1707 in urine measured by Amount excreted unchanged to last quantifiable sample (Aelast)
Time frame: Day -1 until at least Day 7
ASP1707 in urine measured by Renal Clearance (CLR)
Time frame: Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged extrapolated to time = infinity (Aeinf%)
Time frame: Day -1 until at least Day 7
ASP1707 in urine measured by Percentage of the dose excreted unchanged to last quantifiable sample (Aelast %)
Time frame: Day -1 until at least Day 7
2 secondary outcomes
Profiling of metabolites in plasma, urine and feces
Time frame: Day -1 until at least Day 7
Safety assessed by vital signs, 12-lead ECG, laboratory tests, adverse events, physical examination
Time frame: Screening to ESV (up to Day 40)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C-labeled ASP1707 in people with Pharmacokinetics of ASP1707, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radioactivity in whole blood measured by Area under the plasma concentration - to time = infinity (AUCinf) (time frame: Day -1 until at least Day 7). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.