HealthyPhase 1NCT01104532
A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy Subjects
A Phase 1 study testing ASP1941 and sitagliptin in people with Healthy and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetics of ASP1941
- What is being tested?
- ASP1941 and sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2010
- 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
- The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
- The subject's 12-lead electrocardiogram (ECG) results are normal
- The female subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control and not pregnant or lactating
- The male or female subject agrees to practice highly effective birth control from Screening until 7 days post last dose
Who cannot join
- The subject has a history or evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
- The subject has evidence of renal insufficiency (serum creatinine ≥ 1.5 in men and ≥ 1.3 in women)
- The subject has a history of cholelithiasis or acute pancreatitis
- The subject has any condition possibly affecting drug absorption (e.g., gastrectomy)
- The subject has history of consuming more than 14 units of alcoholic beverages per week within last 6 months or has a history of alcoholism or drug/chemical/substance abuse within past 2 years or the subject tests positive for alcohol or drugs of abuse
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in
Show all 13Show fewer
- The subject has a supine mean systolic blood pressure <90 or >160 mm/Hg and a mean diastolic blood pressure <50 or >90, or pulse rate higher than 100 beats per min (bpm)
- The subject has a 12-lead ECG demonstrating QTcF >470 msec (female) or >450 msec (male)
- The subject is known positive for human immunodeficiency virus (HIV) antibody
- The subject has a positive test for tuberculosis (TB), hepatitis C antibody, or positive for hepatitis B surface antigen (HGsAg)
- The subject has used prescription or non-prescription drugs within 14 days or 5 half-lives (whichever is longer) or complementary and alternative medicines (CAM) within 14 days prior to study drug administration (excluding oral contraceptives, hormone replacement therapy [HRT], and acetaminophen)
- The subject has been vaccinated within the last 7 days
- The subject has had any significant blood loss, donated one unit (450 mL) or blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Randomized, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP1941 and Sitagliptin After Separate and Concomitant Administration to Healthy Adult Subjects
The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses.
Read the detailed description
All subjects will be enrolled at one center and confined to the unit for up to 17 days. Subjects will be dosed in the fasting state in one of the four groups.
- Conditions
- Healthy, Pharmacokinetics of ASP1941
- Being tested
- ASP1941, sitagliptin
- Keywords
- ASP1941, Januvia, sitagliptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
oral tablet
sitagliptinDrug
Also called Januvia
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Dosing Regimen 1 | Experimental | Not described Receives: Drug: ASP1941; Drug: sitagliptin |
| Dosing Regimen 2 | Experimental | Not described Receives: Drug: ASP1941; Drug: sitagliptin |
| Dosing Regimen 3 | Experimental | Not described Receives: Drug: ASP1941; Drug: sitagliptin |
| Dosing Regimen 4 | Experimental | Not described Receives: Drug: ASP1941; Drug: sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables assessment through analysis of blood samples
Measured: Day 1 to Day 15
Secondary outcomes (2)
Pharmacodynamic variables assessment through analysis of blood and urine samples
Measured: Day -1 and up to Day 11
Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations
Measured: Day 1 through scheduled group check out (Day 11 and up to Day 15) or early termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104532
- Sponsor's protocol ID
- 1941-CL-0066
- Status last verified
- Apr 2010
- First submitted
- 14 Apr 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP1941 and Sitagliptin After Separate and Concomitant Administration to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01104532
- Acronym / sponsor ID
- 1941-CL-0066
- Conditions
- Healthy, Pharmacokinetics of ASP1941
- Keywords
- ASP1941, Januvia, sitagliptin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Apr 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.
The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses.
Detailed description
All subjects will be enrolled at one center and confined to the unit for up to 17 days. Subjects will be dosed in the fasting state in one of the four groups.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dosing Regimen 1 | Experimental | Drug: ASP1941, Drug: sitagliptin |
| Dosing Regimen 2 | Experimental | Drug: ASP1941, Drug: sitagliptin |
| Dosing Regimen 3 | Experimental | Drug: ASP1941, Drug: sitagliptin |
| Dosing Regimen 4 | Experimental | Drug: ASP1941, Drug: sitagliptin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
- The subject's 12-lead electrocardiogram (ECG) results are normal
- The female subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control and not pregnant or lactating
- The male or female subject agrees to practice highly effective birth control from Screening until 7 days post last dose
Key exclusion criteria (13 listed)
- The subject has a history or evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
- The subject has evidence of renal insufficiency (serum creatinine ≥ 1.5 in men and ≥ 1.3 in women)
- The subject has a history of cholelithiasis or acute pancreatitis
- The subject has any condition possibly affecting drug absorption (e.g., gastrectomy)
- The subject has history of consuming more than 14 units of alcoholic beverages per week within last 6 months or has a history of alcoholism or drug/chemical/substance abuse within past 2 years or the subject tests positive for alcohol or drugs of abuse
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 tablet | Drug | Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3, Dosing Regimen 4 |
| sitagliptinAlso: Januviaoral tablet | Drug | Dosing Regimen 1, Dosing Regimen 2, Dosing Regimen 3, Dosing Regimen 4 |
Primary outcome
Pharmacokinetic variables assessment through analysis of blood samples
Time frame: Day 1 to Day 15
2 secondary outcomes
Pharmacodynamic variables assessment through analysis of blood and urine samples
Time frame: Day -1 and up to Day 11
Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations
Time frame: Day 1 through scheduled group check out (Day 11 and up to Day 15) or early termination.
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 16 Apr 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 director
Astellas Pharma Global Development
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 sitagliptin in people with Healthy and Pharmacokinetics of ASP1941, run by Astellas Pharma Inc at 1 site in United States.
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 13 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 16 Apr 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 United States. 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?
Pharmacokinetic variables assessment through analysis of blood samples (time frame: Day 1 to Day 15). 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 16 Apr 2010.