Pharmacokinetics of ASP015KPhase 1NCT01430065
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy Volunteers
A Phase 1 study testing ASP015K and Tacrolimus in people with Pharmacokinetics of ASP015K and Drug Interactions, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of ASP015K, Drug Interactions, Healthy Subjects
- What is being tested?
- ASP015K and Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
- If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
- Subject is medically healthy, with no clinically significant medical history or abnormalities observed upon physical examination or 12-lead electrocardiogram (ECG)
- Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
Who cannot join
- Subject has a history of chronic diarrhea
- Subject has been vaccinated within the last 60 days prior to study drug administration
- The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease
- Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
- Subject has a history of the human immunodeficiency virus (HIV) antibody
- The subject has an absolute neutrophil count (ANC) < 2500 cells/mm3 Subject has had clinically significant illness within 1 month prior to study drug administration
- Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Miami, Florida, 33014
About this study
Official title: A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Volunteers
This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.
Read the detailed description
The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.
- Being tested
- ASP015K, Tacrolimus
- Keywords
- transplant, ASP015K, tacrolimus, Prograf, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP015KDrug
oral
TacrolimusDrug
Also called Prograf, FK506
oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus and ASP015K | Experimental | Not described Receives: Drug: ASP015K; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment of AUC through the analysis of blood and urine samples
Measured: Up to Day 13
Secondary outcomes (1)
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of ASP015KStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430065
- Sponsor's protocol ID
- 015K-CL-PK02
- Status last verified
- Sep 2011
- First submitted
- 30 Jun 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Single Sequence, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01430065
- Acronym / sponsor ID
- 015K-CL-PK02
- Keywords
- transplant, ASP015K, tacrolimus, Prograf, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Sep 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 characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.
Detailed description
The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus and ASP015K | Experimental | Drug: ASP015K, Drug: Tacrolimus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
- If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
- Subject is medically healthy, with no clinically significant medical history or abnormalities observed upon physical examination or 12-lead electrocardiogram (ECG)
- Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
Key exclusion criteria (7 listed)
- Subject has a history of chronic diarrhea
- Subject has been vaccinated within the last 60 days prior to study drug administration
- The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease
- Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
- Subject has a history of the human immunodeficiency virus (HIV) antibody
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 | Tacrolimus and ASP015K |
| TacrolimusAlso: Prograf, FK506oral | Drug | Tacrolimus and ASP015K |
Primary outcome
Pharmacokinetic assessment of AUC through the analysis of blood and urine samples
Time frame: Up to Day 13
1 secondary outcome
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood and urine samples
Time frame: Up to Day 13
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 7 Sep 2011.
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 and Tacrolimus in people with Pharmacokinetics of ASP015K and Drug Interactions, 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 4 inclusion and 7 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 7 Sep 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 of AUC through the analysis of blood and urine samples (time frame: Up to Day 13). 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 7 Sep 2011.