HealthyPhase 1NCT01373060
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects
A Phase 1 study testing ASP1941 in people with Healthy and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in Taiwan.
Trial summary
This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 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?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Mar 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive
Who cannot join
- Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence
- Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range
- Labo test results deviate from preset normal range
- Receiving treatment, including medication, within 14 days before the study
- Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study
- Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study
Show all 10Show fewer
- Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day
- Employed by the sponsor, delegated CRO or the study site
- Fasting plasma glucose level of < 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8%
- Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of ASP1941 in Healthy Male Taiwanese Subjects
This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.
Read the detailed description
The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.
- Conditions
- Healthy, Pharmacokinetics of ASP1941
- Being tested
- ASP1941, Placebo
- Keywords
- ASP1941, ipragliflozin, plasma glucose, urine glucose
- Medical subject headings
- Glycosuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
Also called ipragliflozin
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1941 group | Experimental | Not described Receives: Drug: ASP1941 |
| placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG
Measured: up to 72 hours
Secondary outcomes (4)
Cmax of ASP1941 plasma concentration
Measured: up to 72 hours
AUC (Area under the curve) of ASP1941 plasma concentration
Measured: up to 72 hours
Changes in plasma glucose
Measured: baseline and up to 72 hours
Changes in urine glucose
Measured: baseline and up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373060
- Sponsor's protocol ID
- 1941-CL-2001
- Status last verified
- Oct 2011
- First submitted
- 31 May 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
- A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of ASP1941 in Healthy Male Taiwanese Subjects
- ClinicalTrials.gov ID
- NCT01373060
- Acronym / sponsor ID
- 1941-CL-2001
- Conditions
- Healthy, Pharmacokinetics of ASP1941
- Keywords
- ASP1941, ipragliflozin, plasma glucose, urine glucose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Jun 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 assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.
Detailed description
The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP1941 group | Experimental | Drug: ASP1941 |
| placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive
Key exclusion criteria (10 listed)
- Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence
- Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range
- Labo test results deviate from preset normal range
- Receiving treatment, including medication, within 14 days before the study
- Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study
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 | ASP1941 group |
| Placebooral | Drug | placebo group |
Primary outcome
Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG
Time frame: up to 72 hours
4 secondary outcomes
Cmax of ASP1941 plasma concentration
Time frame: up to 72 hours
AUC (Area under the curve) of ASP1941 plasma concentration
Time frame: up to 72 hours
Changes in plasma glucose
Time frame: baseline and up to 72 hours
Changes in urine glucose
Time frame: baseline and up to 72 hours
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 in people with Healthy and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in Taiwan.
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 10 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG (time frame: up to 72 hours). 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.