HealthyPhase 1NCT01430078
A Study to Assess the Bioavailability of ASP015K
A Phase 1 study testing ASP015K in people with Healthy, run by Astellas Pharma Inc at 1 site in United Kingdom.
Trial summary
The objective of the study is to assess the bioavailability of ASP015K within the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Oct 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject weighing at least 45 kg and BMI of 18-32 kg/m2
- Subject must demonstrate their ability to swallow an empty size 000 capsule
- 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 during the study
- Subject has a normal 12-lead ECG
- Subject is medically healthy, with no clinically significant medical history or abnormalities
Who cannot join
- Subject has ever sought advice from, or been referred to, a General Practitioner (GP) or counselor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents
- Subject is currently using or has had previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines
- The subject has a positive drugs of abuse test result
- The subject regularly consumes alcohol >21 units per week
- The subject is a current smoker or has smoked within the last 12 months
- The subject has clinically significant abnormal biochemistry, hematology or urinalysis
Show all 20Show fewer
- The subject has a history of gastrointestinal surgery (with the exception of appendectomy unless it was performed within the previous 12 months)
- The subject has a history of clinically significant cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome
- The subject has had radiation exposure from clinical trials exceeding 5 mSv in the last twelve months or 10 mSv in the last five years
- The subject has a history of adverse reaction or allergy to study drug or its excipients The subject suffers from hayfever they must not have or be expecting to have symptoms during the study
- The subject has had acute diarrhoea or constipation in the 7 days before the first study day
- The subject has the presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips)
- The subject has a positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human Immunodeficiency virus HIV results
- The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to study drug administration, or over the counter medication within 7 days prior to study drug administration
- The subject has/had a symptomatic, viral, bacterial, or fungal infection within 1 week prior to clinic check in
- The subject has been vaccinated within the last 90 days
- The subject has participated in a clinical research study involving investigational drugs or dosage forms within the previous 90 days
- 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 90 days or donated plasma within 7 days prior to clinic admission
- The subject has a past history of tuberculosis or absence of evidence of successful TB immunization as assessed at clinical examination of the Bacille Calmette-Guérin (BCG) scar
- The subject has a past history of recurrent herpes simplex or varicella zoster infections
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Limited
Ruddington, Nottingham, NG116JS
About this study
Official title: A Phase 1, Open-Label, 4-Way Crossover Regional Drug Absorption Study to Assess the Bioavailability of ASP015K in Healthy Subjects
The objective of the study is to assess the bioavailability of ASP015K within the gastrointestinal tract.
Read the detailed description
Each subject will participate in four separate study periods. In each period, subjects will be admitted to the clinical unit approximately seven hours on the day prior to being given study drug. Subjects will remain at the clinical research unit for the next 24 hours after they have received study drug. Subjects will return to the clinical research unit at 36 and 48 hours after they have received study drug to give blood samples. There will be a minimum of a four day "washout" period, between each study period.
Under certain circumstances, subjects may be asked to return to the clinical research unit for an additional study period.
- Conditions
- Healthy
- Being tested
- ASP015K
- Keywords
- ASP015K, Healthy subjects, Pharmacokinetics of ASP015K
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP015KDrug
oral tablet
ASP015KDrug
solution via oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | ASP015K oral tablet Receives: Drug: ASP015K |
| Regimen B | Experimental | ASP015K solution delivered to distal small bowel via oral capsule Receives: Drug: ASP015K |
| Regimen C | Experimental | ASP015K solution delivered to ascending colon via oral capsule Receives: Drug: ASP015K |
| Regimen D | Experimental | ASP015K solution delivered to distal transverse colon via oral capsule Receives: Drug: ASP015K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment of AUC through the analysis of blood samples
Measured: Up to 45 days
Secondary outcomes (1)
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma 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
- NCT01430078
- Sponsor's protocol ID
- 015K-CL-PK15
- Other IDs
- 2010-021160-15
- Status last verified
- Sep 2011
- First submitted
- 8 Jun 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 4-Way Crossover Regional Drug Absorption Study to Assess the Bioavailability of ASP015K in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01430078
- Acronym / sponsor ID
- 015K-CL-PK15
- Conditions
- Healthy
- Keywords
- ASP015K, Healthy subjects, Pharmacokinetics of ASP015K
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Sep 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 assess the bioavailability of ASP015K within the gastrointestinal tract.
Detailed description
Each subject will participate in four separate study periods. In each period, subjects will be admitted to the clinical unit approximately seven hours on the day prior to being given study drug. Subjects will remain at the clinical research unit for the next 24 hours after they have received study drug. Subjects will return to the clinical research unit at 36 and 48 hours after they have received study drug to give blood samples. There will be a minimum of a four day "washout" period, between each study period.
Under certain circumstances, subjects may be asked to return to the clinical research unit for an additional study period.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: ASP015KASP015K oral tablet |
| Regimen B | Experimental | Drug: ASP015KASP015K solution delivered to distal small bowel via oral capsule |
| Regimen C | Experimental | Drug: ASP015KASP015K solution delivered to ascending colon via oral capsule |
| Regimen D | Experimental | Drug: ASP015KASP015K solution delivered to distal transverse colon via oral capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject weighing at least 45 kg and BMI of 18-32 kg/m2
- Subject must demonstrate their ability to swallow an empty size 000 capsule
- 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 during the study
- Subject has a normal 12-lead ECG
- Subject is medically healthy, with no clinically significant medical history or abnormalities
Key exclusion criteria (20 listed)
- Subject has ever sought advice from, or been referred to, a General Practitioner (GP) or counselor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents
- Subject is currently using or has had previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines
- The subject has a positive drugs of abuse test result
- The subject regularly consumes alcohol >21 units per week
- The subject is a current smoker or has smoked within the last 12 months
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 | Regimen A |
| ASP015Ksolution via oral capsule | Drug | Regimen B, Regimen C, Regimen D |
Primary outcome
Pharmacokinetic assessment of AUC through the analysis of blood samples
Time frame: Up to 45 days
1 secondary outcome
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples
Time frame: Up to 45 days
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 7 Sep 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
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, run by Astellas Pharma Inc at 1 site in United Kingdom.
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 5 inclusion and 20 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 7 Sep 2011. 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 Kingdom. 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 assessment of AUC through the analysis of blood samples (time frame: Up to 45 days). 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 7 Sep 2011.