HealthyPhase 1NCT01190670
A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus
A Phase 1 study testing Tacrolimus and ASP015K in people with Healthy and Pharmacokinetics of ASP015K and Tacrolimus, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetics of ASP015K and Tacrolimus
- What is being tested?
- Tacrolimus and ASP015K
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject weighing at least 45kg and body mass index (BMI) of 18-32 kg/m2, inclusive
- If female, 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, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
- 12-lead ECG is normal or if abnormal, the abnormality is not clinically significant
- Clinical laboratory test results are within normal limits or not clinically significant
- Medically healthy, with no clinically significant medical history or abnormalities
Who cannot join
- History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
- Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
- Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
- A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
- Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
- History of human immunodeficiency virus (HIV) antibody
Show all 11Show fewer
- Positive tuberculosis (TB) skin test or Quantiferon Gold test
- Vaccinated within the last 30 days prior to study drug administration
- Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
- 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
- Absolute neutrophil count (ANC) <2500 cells/mm3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Subjects
The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.
Read the detailed description
This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.
- Being tested
- Tacrolimus, ASP015K
- Keywords
- ASP015K, tacrolimus, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called FK506, Prograf
Oral and Intravenous
ASP015KDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Group 1 | Experimental | ASP015K, low dose followed by high dose, with oral tacrolimus Receives: Drug: Tacrolimus; Drug: ASP015K |
| Part 1, Group 2 | Experimental | ASP015K, high dose followed by low dose, with oral tacrolimus Receives: Drug: Tacrolimus; Drug: ASP015K |
| Part 2 | Experimental | ASP015K high dose with intravenous tacrolimus Receives: Drug: Tacrolimus; Drug: ASP015K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables assessment through analysis of blood and urine samples
Measured: Days 1-13 and Days 26-33 (Part 1 only) sampled daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190670
- Sponsor's protocol ID
- 015K-CL-PK16
- Status last verified
- Oct 2010
- First submitted
- 11 Aug 2010
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Drug Interaction Study of the Pharmacokinetics of ASP015K and Tacrolimus After Separate and Concomitant Administration to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01190670
- Acronym / sponsor ID
- 015K-CL-PK16
- Keywords
- ASP015K, tacrolimus, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Aug 2010 (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 the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.
Detailed description
This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1, Group 1 | Experimental | Drug: Tacrolimus, Drug: ASP015KASP015K, low dose followed by high dose, with oral tacrolimus |
| Part 1, Group 2 | Experimental | Drug: Tacrolimus, Drug: ASP015KASP015K, high dose followed by low dose, with oral tacrolimus |
| Part 2 | Experimental | Drug: Tacrolimus, Drug: ASP015KASP015K high dose with intravenous tacrolimus |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject weighing at least 45kg and body mass index (BMI) of 18-32 kg/m2, inclusive
- If female, 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, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
- 12-lead ECG is normal or if abnormal, the abnormality is not clinically significant
- Clinical laboratory test results are within normal limits or not clinically significant
Key exclusion criteria (11 listed)
- History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
- Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
- Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
- A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
- Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
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 |
|---|---|---|
| TacrolimusAlso: FK506, PrografOral and Intravenous | Drug | Part 1, Group 1, Part 1, Group 2, Part 2 |
| ASP015KOral | Drug | Part 1, Group 1, Part 1, Group 2, Part 2 |
Primary outcome
Pharmacokinetic variables assessment through analysis of blood and urine samples
Time frame: Days 1-13 and Days 26-33 (Part 1 only) sampled daily
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 14 Oct 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 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 Tacrolimus and ASP015K in people with Healthy and Pharmacokinetics of ASP015K and Tacrolimus, 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 6 inclusion and 11 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 14 Oct 2010. 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 variables assessment through analysis of blood and urine samples (time frame: Days 1-13 and Days 26-33 (Part 1 only) sampled daily). 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 14 Oct 2010.