Bioavailability of ASP015KPhase 1NCT01929577

A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects

A Phase 1 study testing ASP015K in people with Bioavailability of ASP015K and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Bioavailability of ASP015K, 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: 36 participants
Where: 1 siteUnited States
Study dates: May 2013to Aug 2013
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

Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses prior to screening], or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).
Female subject must have a negative pregnancy test at screening and day -1 of treatment period 1.
Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after final study drug administration.
Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.

Who cannot join

Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check-in.
Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), intermittent acetaminophen (to a maximum of 2 g/day).
Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months prior to screening.

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Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening 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) prior to day -1 of treatment period 1.
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 check-in on day -1 of treatment period 1.
Subject has a positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (HAV) (Immunoglobulin [Ig] M), anti-hepatitis C virus (HCV), hepatitis B core antibody, or anti-human immunodeficiency virus (HIV) type 1 or type 2 at screening.
Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold® test or T-SPOT® test at screening.
Subject received any vaccine within 60 days prior to study drug administration.
Subject has an absolute neutrophil count (ANC) < 2000 cells/mm3 or a creatine phosphokinase (CPK) > 1.5 x ULN at screening or day -1 of treatment period 1.
Subject has had major gastrointestinal (GI) surgery or has a medical condition, which may inhibit the absorption and/or metabolism of study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

Parexel - Early Phase Clinical Unit
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects

The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.

Conditions: Bioavailability of ASP015K, Healthy Subjects, Pharmacokinetics of ASP015K, Food Effect of ASP015K
Being tested: ASP015K
Keywords: ASP015K, healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASP015KDrug
oral tablet

Study groups in NCT01929577
Study group	Role	What they receive
ASP015K Test Tablet - Fasting Conditions	Experimental	ASP015K administered as a single tablet under fasting conditions. Receives: Drug: ASP015K
ASP015K Reference Tablet - Fasting Conditions	Experimental	ASP015K administered via multiple tablets under fasting conditions Receives: Drug: ASP015K
ASP015K Test Tablet -Fed Conditions	Experimental	ASP015K administered as a single tablet under fed conditions Receives: Drug: ASP015K

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic parameter of ASP015K: Cmax
Maximum Concentration (Cmax)
Measured: Day 1-4 of each treatment period
Pharmacokinetic parameter of ASP015K: AUClast
Area Under the Curve from time zero to the last measurable time (AUClast)
Measured: Day 1-4 of each treatment period
Pharmacokinetic parameter of ASP015K: AUCinf
Area Under the Curve from time zero extrapolated to infinity (AUCinf)
Measured: Day 1-4 of each treatment period

Secondary outcomes (3)

Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2
Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2)
Measured: Day 1-4 of each treatment period
Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2
Measured: Day 1-4 of each treatment period
Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements
Measured: Up to Day 4 in each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Aug 2013

First posted28 Aug 2013 (estimated)
Study startMay 2013
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bioavailability 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: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01929577
Sponsor's protocol ID: 015K-CL-PK09
Status last verified: Sep 2013
First submitted: 23 Aug 2013
Last updated: 16 Sep 2013
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Dose, Open-Label, 3-Period, Randomized Crossover Study to Assess the Relative Bioavailability Between Two ASP015K Tablet Formulations and the Food Effect on a New Tablet Formulation in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01929577
Acronym / sponsor ID: 015K-CL-PK09
Conditions: Bioavailability of ASP015K, Healthy Subjects, Pharmacokinetics of ASP015K, Food Effect of ASP015K
Keywords: ASP015K, healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
Collaborators: Janssen Biotech, Inc.
Study start: May 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 28 Aug 2013 (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.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ASP015K Test Tablet - Fasting Conditions	Experimental	Drug: ASP015KASP015K administered as a single tablet under fasting conditions.
ASP015K Reference Tablet - Fasting Conditions	Experimental	Drug: ASP015KASP015K administered via multiple tablets under fasting conditions
ASP015K Test Tablet -Fed Conditions	Experimental	Drug: ASP015KASP015K administered as a single tablet under fed conditions

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Female subject must be of non-childbearing potential (i.e., post-menopausal [defined as at least 1 year without menses prior to screening], or documented surgically sterile or status post hysterectomy [at least 1 month prior to screening]).
Female subject must have a negative pregnancy test at screening and day -1 of treatment period 1.
Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after final study drug administration.

Key exclusion criteria (13 listed)

Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
Subject has a known or suspected hypersensitivity to ASP015K, or any components of the formulation used.
Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to first clinic check-in.
Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), intermittent acetaminophen (to a maximum of 2 g/day).

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 tablet	Drug	ASP015K Reference Tablet - Fasting Conditions, ASP015K Test Tablet - Fasting Conditions, ASP015K Test Tablet -Fed Conditions

Primary outcome

Pharmacokinetic parameter of ASP015K: Cmax
Time frame: Day 1-4 of each treatment period
Maximum Concentration (Cmax)
Pharmacokinetic parameter of ASP015K: AUClast
Time frame: Day 1-4 of each treatment period
Area Under the Curve from time zero to the last measurable time (AUClast)
Pharmacokinetic parameter of ASP015K: AUCinf
Time frame: Day 1-4 of each treatment period
Area Under the Curve from time zero extrapolated to infinity (AUCinf)

3 secondary outcomes

Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2
Time frame: Day 1-4 of each treatment period
Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2
Time frame: Day 1-4 of each treatment period
Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements
Time frame: Up to Day 4 in each treatment period

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 16 Sep 2013.

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, Inc.

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 Bioavailability of ASP015K and Healthy Subjects, 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 6 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 16 Sep 2013. 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 parameter of ASP015K: Cmax (time frame: Day 1-4 of each treatment period). 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?

On the ClinicalTrials.gov record for NCT01929577.

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 16 Sep 2013.