Healthy SubjectsPhase 1NCT01406132
A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects
A Phase 1 study testing ASP015K in people with Healthy Subjects and Pharmacokinetics of ASP015K, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The objective of this study is to evaluate pharmacokinetics, in particular the routes of excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled ASP015K. 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, Pharmacokinetics of ASP015K
- What is being tested?
- ASP015K
- 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 States
- Study dates
- Dec 2009to Jan 2010
- 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
- The subject has a body weight of at least 45 kg and a body mass index (BMI) between 18 and 32 kg/m2, inclusive
- The subject has been a non-smoker for at least 3 months prior to check-in
- The subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method to prevent pregnancy during the study period
- The subject's clinical laboratory test results are within normal limits
- The subject is medically healthy, with no clinically significant medical history or abnormalities
Who cannot join
- The subject has a history of any clinically significant gastrointestinal, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer
- The subject has a history of malabsorption syndrome or previous gastrointestinal surgery that could affect drug absorption or metabolism
- The subject has a recent history of irregular defecation, such as constipation or diarrhea
- The subject has a history of drug or alcohol abuse, or a positive urine screen for alcohol or drugs of abuse/illegal drugs
- The subject has had treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter (OTC) medication within past week
- The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in
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- The subject is known positive for human immunodeficiency virus (HIV) antibody
- The subject has a positive test for hepatitis C antibody, or positive test for hepatitis B antigen (HBsAg)
- The subject has positive tuberculosis (TB) or Quantiferon Gold test
- The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
- The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
- The subject has had exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
- The subject has participated in a radio-labeled-study within the last 6 months, participated in more than one other radio-labeled study within the past 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit (CCRU)
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-Label, Mass Balance Study to Evaluate the Pharmacokinetics of ASP015K After a Single Oral Dose of 14C-Labeled ASP015K in Healthy Male Subjects
The objective of this study is to evaluate pharmacokinetics, in particular the routes of excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled ASP015K.
Read the detailed description
Eligible subjects will be admitted to the clinical research unit and confined for a minimum of 8 days.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP015K
- Being tested
- ASP015K
- Keywords
- ASP015K, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP015KDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP015K | Experimental | Not described Receives: Drug: ASP015K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startDec 2009
- Primary completionJan 2010
- Study completionJan 2010
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
- Non-randomised
- 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
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406132
- Sponsor's protocol ID
- 015K-CL-PK03
- Status last verified
- Jul 2011
- First submitted
- 30 Jun 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Mass Balance Study to Evaluate the Pharmacokinetics of ASP015K After a Single Oral Dose of 14C-Labeled ASP015K in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01406132
- Acronym / sponsor ID
- 015K-CL-PK03
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP015K
- Keywords
- ASP015K, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Aug 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.
The objective of this study is to evaluate pharmacokinetics, in particular the routes of excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled ASP015K.
Detailed description
Eligible subjects will be admitted to the clinical research unit and confined for a minimum of 8 days.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP015K | Experimental | Drug: ASP015K |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject has a body weight of at least 45 kg and a body mass index (BMI) between 18 and 32 kg/m2, inclusive
- The subject has been a non-smoker for at least 3 months prior to check-in
- The subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method to prevent pregnancy during the study period
- The subject's clinical laboratory test results are within normal limits
- The subject is medically healthy, with no clinically significant medical history or abnormalities
Key exclusion criteria (13 listed)
- The subject has a history of any clinically significant gastrointestinal, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer
- The subject has a history of malabsorption syndrome or previous gastrointestinal surgery that could affect drug absorption or metabolism
- The subject has a recent history of irregular defecation, such as constipation or diarrhea
- The subject has a history of drug or alcohol abuse, or a positive urine screen for alcohol or drugs of abuse/illegal drugs
- The subject has had treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter (OTC) medication within past week
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 |
|---|---|---|
| ASP015Koral | Drug | ASP015K |
Primary outcome
Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples
Time frame: Up to 10 days
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 1 Aug 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.
Medical Director study director
Astellas Pharma Global Development
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 ASP015K in people with Healthy Subjects and Pharmacokinetics of ASP015K, run by Astellas Pharma Inc at 1 site in United States.
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 5 inclusion and 13 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 1 Aug 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 United States. 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?
Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples (time frame: Up to 10 days). 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 1 Aug 2011.