Bioavailability of IpragliflozinPhase 1NCT01611428
Absolute Bioavailability Study With Ipragliflozin
A Phase 1 study testing Ipragliflozin in people with Bioavailability of Ipragliflozin and Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial summary
A study to assess the absolute bioavailability of ipragliflozin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Ipragliflozin, Healthy Subjects
- What is being tested?
- Ipragliflozin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Jul 2011
- 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
- Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2
Who cannot join
- Any of the liver function tests above the upper limit of normal.
- Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
- A QTc interval of >430 ms (males) or > 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Open-label, Randomized Two-period Crossover Study in Healthy Young Subjects to Assess the Absolute Bioavailability of Ipragliflozin
A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.
- Conditions
- Bioavailability of Ipragliflozin, Healthy Subjects
- Being tested
- Ipragliflozin
- Keywords
- Ipragliflozin, Healthy, Absolute Bioavailability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpragliflozinDrug
Also called ASP1941
Oral and Intravenous (i.v.)
| Study group | Role | What they receive |
|---|---|---|
| Ipragliflozin - oral | Experimental | open label Receives: Drug: Ipragliflozin |
| Ipragliflozin - i.v. | Experimental | open label Receives: Drug: Ipragliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the absolute bioavailability after a single oral dose of ipragliflozin
Measured: 6 days
Secondary outcomes (3)
Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin
AUClast (Area under the plasma concentration-time curve up to the last quantifiable sample), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)
Measured: 6 days
Evaluation of the safety and tolerability of a single oral dose of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
Measured: 3 days
Evaluation of the safety and tolerability of an i.v. administration of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of IpragliflozinStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611428
- Sponsor's protocol ID
- 1941-CL-0057
- Other IDs
- 2010-023813-77
- Status last verified
- May 2012
- First submitted
- 31 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Open-label, Randomized Two-period Crossover Study in Healthy Young Subjects to Assess the Absolute Bioavailability of Ipragliflozin
- ClinicalTrials.gov ID
- NCT01611428
- Acronym / sponsor ID
- 1941-CL-0057
- Conditions
- Bioavailability of Ipragliflozin, Healthy Subjects
- Keywords
- Ipragliflozin, Healthy, Absolute Bioavailability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Jun 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.
A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipragliflozin - oral | Experimental | Drug: Ipragliflozinopen label |
| Ipragliflozin - i.v. | Experimental | Drug: Ipragliflozinopen label |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2
Key exclusion criteria (3 listed)
- Any of the liver function tests above the upper limit of normal.
- Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
- A QTc interval of >430 ms (males) or > 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
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 |
|---|---|---|
| IpragliflozinAlso: ASP1941Oral and Intravenous (i.v.) | Drug | Ipragliflozin - i.v., Ipragliflozin - oral |
Primary outcome
Assessment of the absolute bioavailability after a single oral dose of ipragliflozin
Time frame: 6 days
3 secondary outcomes
Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin
Time frame: 6 days
Evaluation of the safety and tolerability of a single oral dose of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
Time frame: 3 days
Evaluation of the safety and tolerability of an i.v. administration of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)
Time frame: 3 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 5 Jun 2012.
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.
Clinical Study Manager study director
Astellas Pharma Europe B.V.
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 Ipragliflozin in people with Bioavailability of Ipragliflozin and Healthy Subjects, run by Astellas Pharma Europe B.V. 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 1 inclusion and 3 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 5 Jun 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 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?
Assessment of the absolute bioavailability after a single oral dose of ipragliflozin (time frame: 6 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 5 Jun 2012.