HealthyPhase 1NCT01972880
A Study to Compare the Oral Absorption of ASP1941 Among Two Types of Tablets
A Phase 1 study testing ASP1941 in people with Healthy and Plasma Concentration of ASP1941, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed. 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, Plasma Concentration 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
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Jan 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 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight (at screening) >=50.0 kg and < 80kg
- BMI >= 17.6 and < 26.4 (BMI = Weight (kg)/(Height (m))2)
- Healthy, as judged by the investigator/sub-investigator based on physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital of the period 1 admission to immediately before study drug administration
Who cannot join
- Received or scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before the screening or during the period from screening to hospital admission of the period 1 (Day -1).
- Donated or scheduled to donate more than 400 mL of whole blood within 90 days before the screening, more than 200 mL of whole blood within 30 days before screening, blood components within 14 days before screening, or whole blood or blood components during the period from screening to hospital admission of the period 1 (Day -1).
- Received or scheduled to receive medications (including OTC drugs) within 7 days before hospital admission of the period 1 (Day -1).
- A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead ECG at screening or hospital admission of the period 1 (Day -1)
- Concurrent or previous drug allergies
- Development of upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before hospital admission of the period1 (Day-1)
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- Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced hepatic disorder, and hepatic function disorder)
- Concurrent or previous heart disease (e.g., congestive cardiac failure, angina pectoris, and arrhythmia requiring treatment)
- Concurrent or previous gastrointestinal disease (e.g., peptic ulcer and reflux esophagitis), except for a history of appendicitis
- Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis), except for a history of renal calculus
- Concurrent or previous endocrine disease (e.g., hyperthyroidism and blood abnormal growth hormone)
- Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
- Concurrent or previous severe ketosis, diabetic coma, or precoma
- Previous use of ASP1941
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP1941 Pharmacokinetic Study - Verification of Bioequivalence Between ASP1941 New Tablets and ASP1941 Conventional Tablets -
To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed.
Read the detailed description
This study is a open-label randomized two-way crossover study. A single dose of two types of ASP1941 tablets are given to non-elderly healthy male subjects (16 subjects for each group, 32 subjects in total).
In case the bioequivalence of the 2 formulations cannot be proved in this study due to insufficient number of subjects, an add-on subject study will be conducted in this clinical trial as needed. Same design and methodology are to be applied to this study and the add-on subject study. The add-on subject study may not be conducted.
- Conditions
- Healthy, Plasma Concentration of ASP1941
- Being tested
- ASP1941
- Keywords
- Open-label design, Bioequivalence, ASP1941
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 |
|---|---|---|
| tablet-1 | Experimental | Not described Receives: Drug: ASP1941 |
| tablet-2 | Active comparator | Not described Receives: Drug: ASP1941 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of unchanged ASP1941
Measured: Before study drug administration on the administration day (Day 1), and 0.25，0.5，1，1.5，2，2.5，3，4，5，6，8，10，12，24，36，48，72 hours after administration
Secondary outcomes (1)
Safety assessed by vital signs (sitting blood pressure, sitting pulse rate, axillary body temperature), AEs (including subjective symptoms and objective findings), Laboratory tests (hematology, biochemistry, urinalysis) and 12-lead ECGs
Measured: Up to 5 days 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 posted31 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionJan 2014
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972880
- Sponsor's protocol ID
- 1941-CL-7001
- Status last verified
- Feb 2014
- First submitted
- 16 Oct 2013
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP1941 Pharmacokinetic Study - Verification of Bioequivalence Between ASP1941 New Tablets and ASP1941 Conventional Tablets -
- ClinicalTrials.gov ID
- NCT01972880
- Acronym / sponsor ID
- 1941-CL-7001
- Conditions
- Healthy, Plasma Concentration of ASP1941
- Keywords
- Open-label design, Bioequivalence, ASP1941
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Oct 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.
To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed.
Detailed description
This study is a open-label randomized two-way crossover study. A single dose of two types of ASP1941 tablets are given to non-elderly healthy male subjects (16 subjects for each group, 32 subjects in total).
In case the bioequivalence of the 2 formulations cannot be proved in this study due to insufficient number of subjects, an add-on subject study will be conducted in this clinical trial as needed. Same design and methodology are to be applied to this study and the add-on subject study. The add-on subject study may not be conducted.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tablet-1 | Experimental | Drug: ASP1941 |
| tablet-2 | Active comparator | Drug: ASP1941 |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight (at screening) >=50.0 kg and < 80kg
- BMI >= 17.6 and < 26.4 (BMI = Weight (kg)/(Height (m))2)
- Healthy, as judged by the investigator/sub-investigator based on physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital of the period 1 admission to immediately before study drug administration
Key exclusion criteria (14 listed)
- Received or scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before the screening or during the period from screening to hospital admission of the period 1 (Day -1).
- Donated or scheduled to donate more than 400 mL of whole blood within 90 days before the screening, more than 200 mL of whole blood within 30 days before screening, blood components within 14 days before screening, or whole blood or blood components during the period from screening to hospital admission of the period 1 (Day -1).
- Received or scheduled to receive medications (including OTC drugs) within 7 days before hospital admission of the period 1 (Day -1).
- A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead ECG at screening or hospital admission of the period 1 (Day -1)
- Concurrent or previous 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 | tablet-1, tablet-2 |
Primary outcome
Plasma concentration of unchanged ASP1941
Time frame: Before study drug administration on the administration day (Day 1), and 0.25，0.5，1，1.5，2，2.5，3，4，5，6，8，10，12，24，36，48，72 hours after administration
1 secondary outcome
Safety assessed by vital signs (sitting blood pressure, sitting pulse rate, axillary body temperature), AEs (including subjective symptoms and objective findings), Laboratory tests (hematology, biochemistry, urinalysis) and 12-lead ECGs
Time frame: Up to 5 days 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 7 Feb 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.
Medical Director 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 Plasma Concentration 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 3 inclusion and 14 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 Feb 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 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?
Plasma concentration of unchanged ASP1941 (time frame: Before study drug administration on the administration day (Day 1), and 0.25，0.5，1，1.5，2，2.5，3，4，5，6，8，10，12，24，36，48，72 hours after 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 7 Feb 2014.