Pharmacokinetics of ASP015KPhase 1NCT01686217
A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K
A Phase 1 study testing ASP015K ER and ASP015K IR in people with Pharmacokinetics of ASP015K and Food Effect, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of ASP015K, Food Effect, Healthy Volunteers
- What is being tested?
- ASP015K ER and ASP015K IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2012
- 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
- The subject must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2, inclusive at Screening
- If female, the subject is surgically sterile (with documentation provided by a healthcare professional), or is post-menopausal (defined as at least 2 years since last regular menstrual cycle and confirmatory follicle stimulating hormone (FSH) level of ≥ 30 U/L at screening) and the subject is not pregnant as documented by a negative serum pregnancy test at Screening and Day -1 and is not lactating
- If male, 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 and agrees to continue using this method during the study and until 90 days after the last dose of study drug administration
- Male subject must agree to not donate sperm during the study and until 90 days after last dose of study drug administration
- The subject's 12-lead electrocardiogram (ECG) is normal at Screening and Day -1 of initial treatment period or, if abnormal, the abnormality is not clinically significant as determined by the Investigator
- The subject's clinical laboratory test results at Screening and Day -1 are within normal limits unless the Investigator considers the abnormality to be "not clinically significant"
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- The subject is medically healthy, with no clinically significant medical history or abnormalities observed upon physical examination as determined by the Investigator
- The subject is willing and able to comply with the study requirements
- The subject must be capable of swallowing multiple tablets
- The subject is able to consume the FDA high fat breakfast within 30 minutes
Who cannot join
- The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
- The subject has had major GI surgery (such as colectomy, cholecystectomy, etc) which may inhibit the absorption and/or metabolism of study drug
- The subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to Screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
- The subject has a positive test for alcohol or drugs of abuse at Screening or Day -1
- The subject has a positive cotinine test at Screening or Day -1
- The subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to Day -1 (of initial treatment period) with the exception of stable hormone replacement therapy (HRT) and/or occasional use of acetaminophen (up to a maximum of 2 g/day)
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- The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to Day -1
- The subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody at Screening
- The subject has a history of the human immunodeficiency virus (HIV) antibody
- The subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test at Screening
- The subject received any vaccine within 60 days prior to study drug administration
- 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 on Day -1
- The subject has an absolute neutrophil count (ANC) < 2500 cells/mm3 or a CPK > 1.5x upper limit of normal at Screening and Day -1 of initial treatment period
- The subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Compare the Pharmacokinetic Profiles of Three Different Strengths of ASP015K Extended Release Formulation With ASP015K Immediate Release Formulation and to Evaluate Food Effect on Extended Release Strengths in Healthy Volunteers
The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers.
Read the detailed description
Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose treatments with a washout period of at least 7 days separating the dosing between two consecutive treatments. Dosing conditions include both fed and fasted conditions.
- Conditions
- Pharmacokinetics of ASP015K, Food Effect, Healthy Volunteers
- Being tested
- ASP015K ER, ASP015K IR
- Keywords
- ASP015K Extended Release, ASP015K Immediate Release, Food Effect, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP015K ERDrug
oral extended release (ER) at three dosing levels
ASP015K IRDrug
oral immediate release (IR)
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 Treatment A | Experimental | Lowest per tablet dose of ASP015K Extended Release (ER) tablets under fasted conditions Receives: Drug: ASP015K ER |
| Dose Group 1 Treatment B | Active comparator | Medium per tablet dose ASP015K Immediate Release (IR) tablets under fasted conditions for comparison to lowest dose ER fasted conditions Receives: Drug: ASP015K IR |
| Dose Group 1 Treatment C | Experimental | Lowest per tablet dose of ASP015K ER tablets under fed conditions Receives: Drug: ASP015K ER |
| Dose Group 2 Treatment D | Experimental | Medium per tablet dose of ASP015K ER tablets under fasted conditions Receives: Drug: ASP015K ER |
| Dose Group 2 Treatment E | Active comparator | Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to medium dose ER fasted conditions Receives: Drug: ASP015K IR |
| Dose Group 2 Treatment F | Experimental | Medium per tablet dose of ASP015K ER tablets under fed conditions Receives: Drug: ASP015K ER |
| Dose Group 3 Treatment G | Experimental | Highest per tablet dose of ASP015K ER tablets under fasted conditions Receives: Drug: ASP015K ER |
| Dose Group 3 Treatment H | Active comparator | Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to highest dose ER under fasted conditions Receives: Drug: ASP015K IR |
| Dose Group 3 Treatment I | Experimental | Highest dose of ASP015K ER tablets under fed conditions Receives: Drug: ASP015K ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) for ASP015K (in plasma): Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf)
Measured: Day 1-4 of each of 3 dosing periods
PK for ASP015K (in plasma): AUC from time of dosing to last quantifiable concentration (AUClast)
Measured: Days 1-4 of each of 3 dosing periods
PK for ASP015K (in plasma): Maximum concentration (Cmax)
Measured: Days 1-4 of each of 3 dosing periods
Secondary outcomes (2)
PK profile for ASP015K (in plasma): tmax , t1/2 , Vz /F, and CL/F
Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ), apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F)
Measured: Day 1-4 of each of 3 dosing periods
PK profile for metabolites (in plasma): Cmax, AUClast, and AUCinf, tmax,t1/2
Measured: Day 1-4 of each of 3 dosing periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJul 2012
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.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, 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
- NCT01686217
- Sponsor's protocol ID
- 015K-CL-PK51
- Status last verified
- Aug 2015
- First submitted
- 6 Sep 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Compare the Pharmacokinetic Profiles of Three Different Strengths of ASP015K Extended Release Formulation With ASP015K Immediate Release Formulation and to Evaluate Food Effect on Extended Release Strengths in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01686217
- Acronym / sponsor ID
- 015K-CL-PK51
- Conditions
- Pharmacokinetics of ASP015K, Food Effect, Healthy Volunteers
- Keywords
- ASP015K Extended Release, ASP015K Immediate Release, Food Effect, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Sep 2012 (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 purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers.
Detailed description
Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose treatments with a washout period of at least 7 days separating the dosing between two consecutive treatments. Dosing conditions include both fed and fasted conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 Treatment A | Experimental | Drug: ASP015K ERLowest per tablet dose of ASP015K Extended Release (ER) tablets under fasted conditions |
| Dose Group 1 Treatment B | Active comparator | Drug: ASP015K IRMedium per tablet dose ASP015K Immediate Release (IR) tablets under fasted conditions for comparison to lowest dose ER fasted conditions |
| Dose Group 1 Treatment C | Experimental | Drug: ASP015K ERLowest per tablet dose of ASP015K ER tablets under fed conditions |
| Dose Group 2 Treatment D | Experimental | Drug: ASP015K ERMedium per tablet dose of ASP015K ER tablets under fasted conditions |
| Dose Group 2 Treatment E | Active comparator | Drug: ASP015K IRMedium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to medium dose ER fasted conditions |
| Dose Group 2 Treatment F | Experimental | Drug: ASP015K ERMedium per tablet dose of ASP015K ER tablets under fed conditions |
| Dose Group 3 Treatment G | Experimental | Drug: ASP015K ERHighest per tablet dose of ASP015K ER tablets under fasted conditions |
| Dose Group 3 Treatment H | Active comparator | Drug: ASP015K IRMedium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to highest dose ER under fasted conditions |
| Dose Group 3 Treatment I | Experimental | Drug: ASP015K ERHighest dose of ASP015K ER tablets under fed conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2, inclusive at Screening
- If female, the subject is surgically sterile (with documentation provided by a healthcare professional), or is post-menopausal (defined as at least 2 years since last regular menstrual cycle and confirmatory follicle stimulating hormone (FSH) level of ≥ 30 U/L at screening) and the subject is not pregnant as documented by a negative serum pregnancy test at Screening and Day -1 and is not lactating
- If male, 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 and agrees to continue using this method during the study and until 90 days after the last dose of study drug administration
- Male subject must agree to not donate sperm during the study and until 90 days after last dose of study drug administration
- The subject's 12-lead electrocardiogram (ECG) is normal at Screening and Day -1 of initial treatment period or, if abnormal, the abnormality is not clinically significant as determined by the Investigator
Key exclusion criteria (15 listed)
- The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
- The subject has had major GI surgery (such as colectomy, cholecystectomy, etc) which may inhibit the absorption and/or metabolism of study drug
- The subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to Screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
- The subject has a positive test for alcohol or drugs of abuse at Screening or Day -1
- The subject has a positive cotinine test at Screening or Day -1
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 |
|---|---|---|
| ASP015K ERoral extended release (ER) at three dosing levels | Drug | Dose Group 1 Treatment A, Dose Group 1 Treatment C, Dose Group 2 Treatment D, Dose Group 2 Treatment F, Dose Group 3 Treatment G, Dose Group 3 Treatment I |
| ASP015K IRoral immediate release (IR) | Drug | Dose Group 1 Treatment B, Dose Group 2 Treatment E, Dose Group 3 Treatment H |
Primary outcome
Pharmacokinetic (PK) for ASP015K (in plasma): Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf)
Time frame: Day 1-4 of each of 3 dosing periods
PK for ASP015K (in plasma): AUC from time of dosing to last quantifiable concentration (AUClast)
Time frame: Days 1-4 of each of 3 dosing periods
PK for ASP015K (in plasma): Maximum concentration (Cmax)
Time frame: Days 1-4 of each of 3 dosing periods
2 secondary outcomes
PK profile for ASP015K (in plasma): tmax , t1/2 , Vz /F, and CL/F
Time frame: Day 1-4 of each of 3 dosing periods
PK profile for metabolites (in plasma): Cmax, AUClast, and AUCinf, tmax,t1/2
Time frame: Day 1-4 of each of 3 dosing periods
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 Sep 2015.
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 ER and ASP015K IR in people with Pharmacokinetics of ASP015K and Food Effect, run by Astellas Pharma Global Development, 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 10 inclusion and 15 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 Sep 2015. 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 (PK) for ASP015K (in plasma): Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf) (time frame: Day 1-4 of each of 3 dosing periods). The study lists 3 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 1 Sep 2015.