HealthyPhase 1NCT01674777
A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941
A Phase 1 study testing ASP1941 in people with Healthy and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetics of ASP1941
- What is being tested?
- ASP1941
- 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 siteJapan
- Study dates
- Oct 2010to Dec 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 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
- Body weight ; ≥50.0 kg, <80.0 kg
- Body Mass Index ; ≥17.6, <26.4
- Written informed consent has been obtained
Who cannot join
- Received any investigational drugs within 120 days before the screening assessment
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
- Received medication within 7 days before hospital admission
- A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
- History of drug allergies
- With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941
This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.
Read the detailed description
This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".
- Conditions
- Healthy, Pharmacokinetics of ASP1941
- Being tested
- ASP1941
- Keywords
- ASP1941, Food effect, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
Also called ipragliflozin
oral
| Study group | Role | What they receive |
|---|---|---|
| under fasting condition group | Experimental | Subjects will receive a single dose of ASP1941 under fasting condition Receives: Drug: ASP1941 |
| before meal group | Experimental | Subjects will receive a single dose of ASP1941 before meal Receives: Drug: ASP1941 |
| after meal condition | Experimental | Subjects will receive a single dose of ASP1941 after meal Receives: Drug: ASP1941 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
Measured: For 72 hours after each administration
Secondary outcomes (3)
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance
Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )
Measured: For 72 hours after each administration
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
Measured: For 72 hours after each administration
Changes in urinary glucose excretion
Measured: Before and for 72 hours after each administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674777
- Sponsor's protocol ID
- 1941-CL-0071
- Status last verified
- Aug 2012
- First submitted
- 21 Aug 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941
- ClinicalTrials.gov ID
- NCT01674777
- Acronym / sponsor ID
- 1941-CL-0071
- Conditions
- Healthy, Pharmacokinetics of ASP1941
- Keywords
- ASP1941, Food effect, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Aug 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.
This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.
Detailed description
This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| under fasting condition group | Experimental | Drug: ASP1941Subjects will receive a single dose of ASP1941 under fasting condition |
| before meal group | Experimental | Drug: ASP1941Subjects will receive a single dose of ASP1941 before meal |
| after meal condition | Experimental | Drug: ASP1941Subjects will receive a single dose of ASP1941 after meal |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
- Body weight ; ≥50.0 kg, <80.0 kg
- Body Mass Index ; ≥17.6, <26.4
- Written informed consent has been obtained
Key exclusion criteria (6 listed)
- Received any investigational drugs within 120 days before the screening assessment
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
- Received medication within 7 days before hospital admission
- A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
- History of drug allergies
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 |
|---|---|---|
| ASP1941Also: ipragliflozinoral | Drug | after meal condition, before meal group, under fasting condition group |
Primary outcome
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
Time frame: For 72 hours after each administration
Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
3 secondary outcomes
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance
Time frame: For 72 hours after each administration
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
Time frame: For 72 hours after each administration
Changes in urinary glucose excretion
Time frame: Before and for 72 hours after each administration
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 29 Aug 2012.
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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.
Use Central Contact study chair
Astellas Pharma 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 ASP1941 in people with Healthy and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in Japan.
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 4 inclusion and 6 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 29 Aug 2012. 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 Japan. 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?
Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax (time frame: For 72 hours after each administration). 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 29 Aug 2012.