HealthyPhase 1NCT01288885
First in Men Study of Single Oral Doses of ASP1941 in Healthy Subjects
A Phase 1 study testing ASP1941 in people with Healthy, run by Astellas Pharma Inc at 1 site in United Kingdom.
Trial summary
This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2006to May 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight between 60-100 kg, body mass index (BMI) between 20-30 kg/m2, inclusive
Who cannot join
- Fasting Plasma Glucose (FPG) > 6.4 mmol/l
- HbA1c > 6.2%
- Pulse <40 or >90 beats per minute; Systolic Blood Pressure (SBP) <90 or >140 mmHg; Diastolic Blood Pressure (DBP) <40 or >95mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of Single Oral Doses of ASP1941 in Healthy Male Subjects
This study determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).
Read the detailed description
This study consists of two parts. Part A is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the PK of ASP1941.
- Conditions
- Healthy
- Being tested
- ASP1941, Placebo
- Keywords
- ASP1941, Diabetes Mellitus, First in Men
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
Oral
PlaceboDrug
Oral
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
Measured: Up to 2 weeks after each administration
Secondary outcomes (2)
Pharmacokinetics calculated by ASP1941 plasma concentration change
Measured: Up to 72 hours
Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine
Measured: 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 posted3 Feb 2011 (estimated)
- Study startNov 2006
- Primary completionMay 2007
- Study completionMay 2007
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288885
- Sponsor's protocol ID
- 1941-CL-0001
- Other IDs
- 2006-002719-28
- Status last verified
- Feb 2011
- First submitted
- 1 Feb 2011
- Last updated
- 3 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of Single Oral Doses of ASP1941 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01288885
- Acronym / sponsor ID
- 1941-CL-0001
- Conditions
- Healthy
- Keywords
- ASP1941, Diabetes Mellitus, First in Men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 3 Feb 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 determined the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 after a single oral dose (Part A). In addition, it was investigated whether the intake of food had an effect on the PK of ASP1941 (Part B).
Detailed description
This study consists of two parts. Part A is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of ASP1941. Part B is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the PK of ASP1941.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body weight between 60-100 kg, body mass index (BMI) between 20-30 kg/m2, inclusive
Key exclusion criteria (3 listed)
- Fasting Plasma Glucose (FPG) > 6.4 mmol/l
- HbA1c > 6.2%
- Pulse <40 or >90 beats per minute; Systolic Blood Pressure (SBP) <90 or >140 mmHg; Diastolic Blood Pressure (DBP) <40 or >95mmHg
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 | – |
| PlaceboOral | Drug | – |
Primary outcome
Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests
Time frame: Up to 2 weeks after each administration
2 secondary outcomes
Pharmacokinetics calculated by ASP1941 plasma concentration change
Time frame: Up to 72 hours
Pharmacodynamics assessed by ASP1941 glucose concentration changes in blood and urine
Time frame: 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 3 Feb 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 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 ASP1941 in people with Healthy, run by Astellas Pharma Inc 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 3 Feb 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 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?
Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests (time frame: Up to 2 weeks 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 3 Feb 2011.