Healthy SubjectsPhase 1NCT01302132
Mass Balance Study of ASP1941
A Phase 1 study testing ASP1941 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Netherlands.
Trial summary
This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ASP1941
- Type of treatment
- Pill or oral medicine
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2008to Oct 2008
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive
Who cannot join
- Pulse <40 or >90 bpm; Systolic Blood Pressure > 140 mmHg; Diastolic Blood Pressure >90 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects
This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.
- Conditions
- Healthy Subjects
- Being tested
- ASP1941
- Keywords
- Mass Balance, ASP1941, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
Oral solution
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of ASP1941 to evaluate metabolism and excretion
Measured: up to 216 hours
Secondary outcomes (1)
Identification of metabolic profile of ASP1941
Measured: up to 216 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302132
- Sponsor's protocol ID
- 1941-CL-0055
- Other IDs
- 2008-000316-33, 2008
- Status last verified
- Feb 2011
- First submitted
- 21 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01302132
- Acronym / sponsor ID
- 1941-CL-0055
- Conditions
- Healthy Subjects
- Keywords
- Mass Balance, ASP1941, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Feb 2011 (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.
This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive
Key exclusion criteria (1 listed)
- Pulse <40 or >90 bpm; Systolic Blood Pressure > 140 mmHg; Diastolic Blood Pressure >90 mmHg
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 |
|---|---|---|
| ASP1941Oral solution | Drug | – |
Primary outcome
Pharmacokinetics of ASP1941 to evaluate metabolism and excretion
Time frame: up to 216 hours
1 secondary outcome
Identification of metabolic profile of ASP1941
Time frame: up to 216 hours
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 23 Feb 2011.
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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.
Use Central Contact study director
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 ASP1941 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Netherlands.
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 1 inclusion and 1 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 23 Feb 2011. 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 Netherlands. 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?
Pharmacokinetics of ASP1941 to evaluate metabolism and excretion (time frame: up to 216 hours). 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 23 Feb 2011.