Healthy SubjectsPhase 1NCT01387087
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K
A Phase 1 study testing ASP015K in people with Healthy Subjects and Pharmacokinetics of ASP015K, run by Astellas Pharma Inc at 2 sites in United States.
Trial summary
The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics 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
- Healthy Subjects, 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
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Nov 2008
- 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
- 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 abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
- Subject's fasting clinical laboratory values are within normal limits
- Subject is a non-smoker and has not used tobacco for a minimum of 3 months
- 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 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
- Subject has a history of severe allergic or anaphylactic reactions
- Subject has a history of chronic diarrhea
- Subject has been vaccinated within the last 60 days prior to study drug administration
- Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
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- Subject has had clinically significant illness within 1 month prior to study drug administration
- Subject has a history of hemorrhoids
- Subject has a history of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse and/or illegal drugs
- Subject has had treatment with prescription medication (except hormone replacement therapy and acetaminophen), complementary and alternative medicines (CAM) within 14 days, over-the-counter products within 1 week, or alcohol, caffeine or grapefruit juice within 24 hours prior to study drug administration
- Subject has had treatment with another investigational drug or approved therapy for investigational use within 30 days or 10 half-lives, whichever is longer, prior to study drug administration or has participated in a prior group in the current study
- Subject has a history of blood donation within 30 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014
Prism Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Oral Doses to Healthy Volunteers
The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.
Read the detailed description
Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.
Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP015K
- Being tested
- ASP015K, Placebo
- Keywords
- ASP015K, Healthy subjects, Pharmacodynamics, Maximum tolerated dose
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 |
|---|---|---|
| Group A | Experimental | Lowest dose, all males, fasting Receives: Drug: ASP015K |
| Group B | Experimental | Second lowest dose, all males, fasting Receives: Drug: ASP015K |
| Group C | Experimental | Third lowest dose, all males, fasting Receives: Drug: ASP015K |
| Group D | Experimental | Middle dose, all males, fasting Receives: Drug: ASP015K |
| Group E | Experimental | Third lowest dose, all females, fasting Receives: Drug: ASP015K |
| Group F | Experimental | Third highest dose, all males, fasting then fed Receives: Drug: ASP015K |
| Group G | Experimental | Second highest dose, all males, fasting Receives: Drug: ASP015K |
| Group H | Experimental | Highest dose, all males, fasting Receives: Drug: ASP015K |
| Group I | Experimental | Second highest dose, all females, fasting Receives: Drug: ASP015K |
| Placebo Group A | Placebo comparator | all male, fasting Receives: Drug: Placebo |
| Placebo Group B | Placebo comparator | all male, fasting then fed Receives: Drug: Placebo |
| Placebo Group C | Placebo comparator | all female, fasting Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples
Measured: 8 days
Pharmacokinetic assessment through the analysis of blood and urine samples
Measured: Up to Day 4
Pharmacodynamic assessment through the analysis of blood samples
Measured: Up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJul 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387087
- Sponsor's protocol ID
- 015K-CL-HV01
- Status last verified
- Jun 2011
- First submitted
- 30 Jun 2011
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Oral Doses to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01387087
- Acronym / sponsor ID
- 015K-CL-HV01
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP015K
- Keywords
- ASP015K, Healthy subjects, Pharmacodynamics, Maximum tolerated dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Jul 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.
The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.
Detailed description
Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.
Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: ASP015KLowest dose, all males, fasting |
| Group B | Experimental | Drug: ASP015KSecond lowest dose, all males, fasting |
| Group C | Experimental | Drug: ASP015KThird lowest dose, all males, fasting |
| Group D | Experimental | Drug: ASP015KMiddle dose, all males, fasting |
| Group E | Experimental | Drug: ASP015KThird lowest dose, all females, fasting |
| Group F | Experimental | Drug: ASP015KThird highest dose, all males, fasting then fed |
| Group G | Experimental | Drug: ASP015KSecond highest dose, all males, fasting |
| Group H | Experimental | Drug: ASP015KHighest dose, all males, fasting |
| Group I | Experimental | Drug: ASP015KSecond highest dose, all females, fasting |
| Placebo Group A | Placebo comparator | Drug: Placeboall male, fasting |
| Placebo Group B | Placebo comparator | Drug: Placeboall male, fasting then fed |
| Placebo Group C | Placebo comparator | Drug: Placeboall female, fasting |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
- Subject's fasting clinical laboratory values are within normal limits
- Subject is a non-smoker and has not used tobacco for a minimum of 3 months
Key exclusion criteria (12 listed)
- 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
- Subject has a history of severe allergic or anaphylactic reactions
- Subject has a history of chronic diarrhea
- Subject has been vaccinated within the last 60 days prior to study drug administration
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 | Group A, Group B, Group C, Group D, Group E, Group F, Group G, Group H, Group I |
| Placebooral | Drug | Placebo Group A, Placebo Group B, Placebo Group C |
Primary outcome
Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples
Time frame: 8 days
Pharmacokinetic assessment through the analysis of blood and urine samples
Time frame: Up to Day 4
Pharmacodynamic assessment through the analysis of blood samples
Time frame: Up to Day 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 Jul 2011.
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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.
Medical Director study director
Astellas Pharma Global Development
2 sites 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 Subjects and Pharmacokinetics of ASP015K, run by Astellas Pharma Inc at 2 sites 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 12 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 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples (time frame: 8 days). 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 4 Jul 2011.