Healthy VolunteerPhase 1NCT01121198
A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects
A Phase 1 study testing ASP1941 in people with Healthy Volunteer and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy 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 Volunteer, 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
- 84 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2006to Jul 2007
- 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: 50.0 kg ≤ weight < 85.0 kg
- Body mass index:17.6 ≤ BMI < 26.4
- Those who provided written informed consent themselves
Who cannot join
- Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
- Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
- Those whose lab-test results are in the abnormal range
- Those who received medical treatment within 14 days prior to the study
- Those who attended another clinical study or a post-marketing clinical trial within 120 days before the study
- Those who have received ASP1941 before
- Those who have donated at least 400ml of whole blood within 90 days before the study, at least 200ml 30 days before the study or blood component within 14 days before the study
- Those within a fasting plasma glucose level of < 70mg/dL or 110 mg/dL or with an HbA1C. 5.8%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-
This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.
Read the detailed description
This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.
- Conditions
- Healthy Volunteer, Pharmacokinetics of ASP1941
- Being tested
- ASP1941, placebo
- Keywords
- Food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
oral
placeboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1941 single arm | Experimental | Not described Receives: Drug: ASP1941 |
| ASP1941 repeated arm | Experimental | Not described Receives: Drug: ASP1941 |
| placebo single arm | Placebo comparator | Not described Receives: Drug: placebo |
| placebo repeated arm | 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 adverse events, vital signs, 12-lead ECG and lab-tests
Measured: 72 hours after drug administration
Secondary outcomes (3)
Plasma concentration of unchanged drug measured by blood sample
Measured: 72 hours after drug administration
Blood glucose level measured by blood sample
Measured: 72 hours after drug administration
Urinary glucose excretion level
Measured: 72 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startDec 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121198
- Sponsor's protocol ID
- 1941-CL-0101
- Status last verified
- May 2010
- First submitted
- 10 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP1941 Phase I Study -Placebo-controlled, Single-dose and Repeated-dose Oral Administration Study in Healthy Adult Male Subjects-
- ClinicalTrials.gov ID
- NCT01121198
- Acronym / sponsor ID
- 1941-CL-0101
- Conditions
- Healthy Volunteer, Pharmacokinetics of ASP1941
- Keywords
- Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 May 2010 (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 safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.
Detailed description
This study consists of two parts. In part-1, a single oral dose of ASP1941 or placebo is administered to healthy adult male subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy adult males. In part-2, ASP1941 or placebo are is administered by a multiple dose regimen.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP1941 single arm | Experimental | Drug: ASP1941 |
| ASP1941 repeated arm | Experimental | Drug: ASP1941 |
| placebo single arm | Placebo comparator | Drug: placebo |
| placebo repeated arm | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight: 50.0 kg ≤ weight < 85.0 kg
- Body mass index:17.6 ≤ BMI < 26.4
- Those who provided written informed consent themselves
Key exclusion criteria (8 listed)
- Medical history of Hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disease, malignant tumor or drug allergy
- Those whose blood pressure, pulse rate, body temperature or 12-lead ECG are in the abnormal range
- Those whose lab-test results are in the abnormal range
- Those who received medical treatment within 14 days prior to the study
- Those who attended another clinical study or a post-marketing clinical trial within 120 days 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 |
|---|---|---|
| ASP1941oral | Drug | ASP1941 repeated arm, ASP1941 single arm |
| placebooral | Drug | placebo repeated arm, placebo single arm |
Primary outcome
Safety assessed by adverse events, vital signs, 12-lead ECG and lab-tests
Time frame: 72 hours after drug administration
3 secondary outcomes
Plasma concentration of unchanged drug measured by blood sample
Time frame: 72 hours after drug administration
Blood glucose level measured by blood sample
Time frame: 72 hours after drug administration
Urinary glucose excretion level
Time frame: 72 hours after drug 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 May 2010.
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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 Volunteer 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 3 inclusion and 8 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 May 2010. 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. 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 adverse events, vital signs, 12-lead ECG and lab-tests (time frame: 72 hours after drug 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 May 2010.