HealthyPhase 1NCT01403818
A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration
A Phase 1 study testing ASP1941 and Mitiglinide calcium hydrate in people with Healthy and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers. 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, Pharmacokinetics of Mitiglinide
- What is being tested?
- ASP1941 and Mitiglinide calcium hydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2011to Aug 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 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 kg/m2
- 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
- Previous treatment with ASP1941
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate
This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.
Read the detailed description
This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.
- Being tested
- ASP1941, Mitiglinide calcium hydrate
- Keywords
- ASP1941, ipragliflozin, Mitiglinide calcium hydrate, Drug-Drug interaction, 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
Mitiglinide calcium hydrateDrug
Also called Glufast
oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders. Receives: Drug: ASP1941; Drug: Mitiglinide calcium hydrate |
| Part 2 | Experimental | Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders. Receives: Drug: ASP1941; Drug: Mitiglinide calcium hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change
Measured: For up to 72 hours after each administration
Secondary outcomes (2)
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
Measured: For up to 10 days
Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change
Measured: For 72 hours after ASP1941 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- 60 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
- NCT01403818
- Sponsor's protocol ID
- 1941-CL-0074
- Status last verified
- Oct 2011
- First submitted
- 25 Jul 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate
- ClinicalTrials.gov ID
- NCT01403818
- Acronym / sponsor ID
- 1941-CL-0074
- Keywords
- ASP1941, ipragliflozin, Mitiglinide calcium hydrate, Drug-Drug interaction, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 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.
This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.
Detailed description
This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: ASP1941, Drug: Mitiglinide calcium hydrateSubjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders. |
| Part 2 | Experimental | Drug: ASP1941, Drug: Mitiglinide calcium hydrateSubjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders. |
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 kg/m2
- Written informed consent has been obtained
Key exclusion criteria (7 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 | Part 1, Part 2 |
| Mitiglinide calcium hydrateAlso: Glufastoral | Drug | Part 1, Part 2 |
Primary outcome
Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change
Time frame: For up to 72 hours after each administration
2 secondary outcomes
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
Time frame: For up to 10 days
Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change
Time frame: For 72 hours after ASP1941 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 12 Oct 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.
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 and Mitiglinide calcium hydrate 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 7 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 12 Oct 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 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 of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change (time frame: For up to 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 12 Oct 2011.