Healthy VolunteersPhase 1NCT02141425
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects
A Phase 1 study testing ASP015K in people with Healthy Volunteers and Pharmacokinetics of ASP015K, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single ascending doses of ASP015K. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pharmacokinetics of ASP015K
- What is being tested?
- ASP015K
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2014
- 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 either:
- Of non-childbearing potential:
- postmenopausal (defined as at least 1 year without any menses) prior to screening,
- or documented surgically sterile or status post-hysterectomy (at least 1 month prior to screening).
- Or, if of childbearing potential:
- must have a negative pregnancy test at screening and day -1.
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- must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and throughout the study period and for 90 days after final study drug administration.
- 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 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study period, and for 90 days after final study drug administration.
- Male subject must not donate sperm starting at screening and continuing throughout the study period, and for 90 days after final study drug administration.
- Subject has a Body Mass Index (BMI) range of 18.5 to 32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.
- Subject must be capable of swallowing multiple (up to 20) tablets.
- Subject agrees not to participate in another investigational study while on treatment.
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 formulations used.
- Subject has any of the liver function tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase or total bilirubin) above the ULN at screening or day -1. If the result is outside the limits, the assessment may be repeated once at screening and day -1.
- Subject has any clinically significant history of allergic conditions.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal (GI), endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, as judged by the investigator or designee.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (non-cutaneous) infection within 1 week prior to day -1.
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- Subject has any clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or day -1.
- Subject has a mean pulse < 40 or > 90 beats per minute, mean systolic blood pressure (BP) > 140 mmHg or mean diastolic BP > 90 mmHg (measurements taken in triplicate after subject has been resting in sitting position for 5 minutes) at screening or day -1.
- Subject has a mean QTcF interval of > 430 msec (for males) and > 450 msec (for females) at screening or day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken. If this triplicate also gives an abnormal result, the subject should be excluded.
- 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), hormonal contraceptives and intermittent acetaminophen (no more than 2g per day).
- Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past 6 months prior to screening.
- 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 the past 2 years prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- Subject has a positive test for alcohol, drugs of abuse or cotinine at screening or day -1.
- Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville oranges (including marmalade), star fruit or any products containing these items from 72 hours prior to day -1 and throughout the duration of the study.
- Subject has used any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to day -1.
- Subject has had any significant blood loss, donated 1 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 day -1.
- Subject has a positive test for hepatitis B surface antigen, anti-hepatitis A virus (Immunoglobulin M) antibody, anti-hepatitis C virus antibody, hepatitis B core antibody or anti-human immunodeficiency virus Type 1 or Type 2 at screening.
- Subject has a positive tuberculosis skin test, Quantiferon Gold® or T-SPOT® test at screening.
- Subject has 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. If the result is outside the limits, the assessment may be repeated once at screening and day -1.
- Subject has had major GI surgery or has a medical condition that may inhibit the absorption and/or metabolism of study drug.
- Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
- Subject has any other condition, which in the opinion of the investigator, precludes the subject's participation in the study.
- Subject is an employee of the Astellas Group, Janssen Pharmaceuticals or vendors involved in the study.
- Subject has participated in a prior study with ASP015K.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group/Parexel
Glendale, California, 91206
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Doses in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single ascending doses of ASP015K.
Read the detailed description
Subjects will be enrolled in 1 of 3 dose cohorts (low, medium and high). Each cohort will consist of 8 subjects with a 3:1 randomization ratio for ASP015K to placebo. Subjects will be confined to the clinic for study procedures until day 4 (5 days). After all subjects in a dose cohort have completed study procedures through day 4, a decision will be made whether or not dosing and enrollment of the next dose cohort should occur, which will only take place after a review of the safety and tolerability data through day 4 of the most recent dose cohort and any additional reported adverse events (AEs) for previously dosed cohorts.
- Conditions
- Healthy Volunteers, Pharmacokinetics of ASP015K
- Being tested
- ASP015K, Placebo
- Keywords
- Healthy volunteers, ASP015K
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP015KDrug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP015K low dose | Experimental | Not described Receives: Drug: ASP015K |
| ASP015K medium dose | Experimental | Not described Receives: Drug: ASP015K |
| ASP015K high dose | Experimental | Optional, depending on safety review and regulatory authority input Receives: Drug: ASP015K |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by adverse events, clinical laboratory tests, electrocardiogram (ECG) measurements, physical examination abnormalities and vital signs
Measured: Days 1-4
Secondary outcomes (2)
Pharmacokinetic profile of ASP015K: Cmax, AUClast, AUCinf, tmax, t1/2, CL/F, Vz/F
Maximum Concentration (Cmax), Area Under the Plasma Concentration - Time Curve from Time Zero to Time of Last Measurable Concentration (AUClast), Area Under the Plasma concentration - Time Curve from Time Zero to Infinity (AUCinf), Time of Attain Cmax (tmax), Apparent Terminal Elimination Half-life (t1/2), Apparent total systemic clearance (CL/F), apparent volume of distribution (Vz/F)
Measured: Days 1-4
Pharmacokinetic profile of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2
Measured: Days 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141425
- Sponsor's protocol ID
- 015K-CL-HV07
- Status last verified
- Jun 2014
- First submitted
- 15 May 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02141425
- Acronym / sponsor ID
- 015K-CL-HV07
- Conditions
- Healthy Volunteers, Pharmacokinetics of ASP015K
- Keywords
- Healthy volunteers, ASP015K
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 May 2014 (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 assess the safety, tolerability and pharmacokinetics of single ascending doses of ASP015K.
Detailed description
Subjects will be enrolled in 1 of 3 dose cohorts (low, medium and high). Each cohort will consist of 8 subjects with a 3:1 randomization ratio for ASP015K to placebo. Subjects will be confined to the clinic for study procedures until day 4 (5 days). After all subjects in a dose cohort have completed study procedures through day 4, a decision will be made whether or not dosing and enrollment of the next dose cohort should occur, which will only take place after a review of the safety and tolerability data through day 4 of the most recent dose cohort and any additional reported adverse events (AEs) for previously dosed cohorts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP015K low dose | Experimental | Drug: ASP015K |
| ASP015K medium dose | Experimental | Drug: ASP015K |
| ASP015K high dose | Experimental | Drug: ASP015KOptional, depending on safety review and regulatory authority input |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Female subject must be either:
- 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 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study period, and for 90 days after final study drug administration.
- Male subject must not donate sperm starting at screening and continuing throughout the study period, and for 90 days after final study drug administration.
- Subject has a Body Mass Index (BMI) range of 18.5 to 32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.
Key exclusion criteria (25 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 formulations used.
- Subject has any of the liver function tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase or total bilirubin) above the ULN at screening or day -1. If the result is outside the limits, the assessment may be repeated once at screening and day -1.
- Subject has any clinically significant history of allergic conditions.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal (GI), endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, as judged by the investigator or designee.
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 high dose, ASP015K low dose, ASP015K medium dose |
| Placebooral | Drug | Placebo |
Primary outcome
Safety as assessed by adverse events, clinical laboratory tests, electrocardiogram (ECG) measurements, physical examination abnormalities and vital signs
Time frame: Days 1-4
2 secondary outcomes
Pharmacokinetic profile of ASP015K: Cmax, AUClast, AUCinf, tmax, t1/2, CL/F, Vz/F
Time frame: Days 1-4
Pharmacokinetic profile of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2
Time frame: Days 1-4
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 4 Jun 2014.
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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.
Senior 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 Healthy Volunteers and Pharmacokinetics of ASP015K, 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 13 inclusion and 25 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 4 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
Safety as assessed by adverse events, clinical laboratory tests, electrocardiogram (ECG) measurements, physical examination abnormalities and vital signs (time frame: Days 1-4). 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 4 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.