ObesityPhase 1NCT00842400
A Drug Interaction Study of VI-0521 With Metformin, Sitagliptan and Probenecid in Healthy Subjects.
A Phase 1 study testing Metformin, VI-0521, Sitagliptan, Probenecid in people with Obesity, run by VIVUS LLC at 1 site in United States.
Trial summary
The purposes of this study are to: Find out how much of the study drugs are in the blood of healthy subjects after taking multiple doses of VI-0521, metformin and sitagliptan. Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy subjects after taking multiple doses. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Metformin, VI-0521, Sitagliptan, Probenecid
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Apr 2009
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study population will consist of adult healthy males or females, 19-45 years of age; inclusive who are medically healthy with no clinically significant screening results.
Who cannot join
- Main exclusion criteria include a history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator; any clinically significant laboratory abnormalities as judged by the Investigator; any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure; presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy; any history of a cardiovascular or cerebrovascular event; any active malignancy except basal cell carcinoma; systolic blood pressure > 150 mm Hg or diastolic blood pressure > 95 mm Hg at screening or at check-in (Two rechecks are allowed); positive drug/alcohol test at screening or check in; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing. In female subjects, a positive pregnancy test at screening or check-in is exclusionary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Open-Label, Non-randomized, One-Sequence Crossover, Pharmacokinetic Interaction Study of the Combination Product VI-0521 (Phentermine Plus Topiramate) With Metformin, Sitagliptin or Probenecid in Healthy Subjects
The purposes of this study are to:
- Find out how much of the study drugs are in the blood of healthy subjects after taking multiple doses of VI-0521, metformin and sitagliptan.
- Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy subjects after taking multiple doses.
- Find out how much topiramate is in the semen of healthy male subjects after taking multiple doses.
Read the detailed description
This trial is an open-label, non-randomized, one-sequence crossover study. All subjects will receive an oral dose of metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34; an oral dose of sitagliptin 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39 and a single oral dose of VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39) plus a single oral dose of 2 g (four 500 mg) probenecid tablets on Day 29.
Subjects will remain at the site for the duration of the study (from Day -1 to Day 40). Blood samples for the determination of metformin concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours after the morning administration of metformin or metformin plus VI-0521 on Days 5 and 34. Blood samples for the determination of sitagliptin concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 5, 7, 10, 16 and 24 hours after the administration of sitagliptin or sitagliptin plus VI-0521 on Days 10 and 39. Blood samples for the determination of phentermine and topiramate concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 5, 7, 10, 16 and 24 hours after the administration of the investigational product(s) on Days 28, 29, 34 and 39. Pre-dose blood samples for determination of the investigational drug concentrations in plasma will be taken in the morning on Days 4 and 33 for metformin; Days 9 and 38 for sitagliptin and Days 27, 33 and 38 for phentermine and topiramate. Semen samples for determination of topiramate concentrations will be collected on Day 28 between five and seven hours after VI-0521 administration in 8 male non-vasectomized subjects to obtain at least 6 evaluable subjects.
The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin.The secondary endpoint is the topiramate concentration in semen.
- Conditions
- Obesity
- Being tested
- Metformin, VI-0521, Sitagliptan, Probenecid
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin, VI-0521, Sitagliptan, ProbenecidDrug
Also called VI-0521, Sitagliptan, Metformin, Probenecid
This trial is an open-label, non-randomized, one-sequence crossover study.
- metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34
- sitagliptan 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39
- VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39)
- 2 g (four 500 mg) probenecid tablets on Day 29.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin.
Measured: 40 days
Secondary outcomes (1)
The secondary endpoint is the topiramate concentration in semen.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shiyin Yee, Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842400
- Sponsor's protocol ID
- OB-107
- Status last verified
- Jan 2010
- First submitted
- 6 Feb 2009
- Last updated
- 21 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label, Non-randomized, One-Sequence Crossover, Pharmacokinetic Interaction Study of the Combination Product VI-0521 (Phentermine Plus Topiramate) With Metformin, Sitagliptin or Probenecid in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00842400
- Acronym / sponsor ID
- OB-107
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Feb 2009 (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 purposes of this study are to:
- Find out how much of the study drugs are in the blood of healthy subjects after taking multiple doses of VI-0521, metformin and sitagliptan.
- Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy subjects after taking multiple doses.
- Find out how much topiramate is in the semen of healthy male subjects after taking multiple doses.
Detailed description
This trial is an open-label, non-randomized, one-sequence crossover study. All subjects will receive an oral dose of metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34; an oral dose of sitagliptin 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39 and a single oral dose of VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39) plus a single oral dose of 2 g (four 500 mg) probenecid tablets on Day 29.
Subjects will remain at the site for the duration of the study (from Day -1 to Day 40). Blood samples for the determination of metformin concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours after the morning administration of metformin or metformin plus VI-0521 on Days 5 and 34. Blood samples for the determination of sitagliptin concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 5, 7, 10, 16 and 24 hours after the administration of sitagliptin or sitagliptin plus VI-0521 on Days 10 and 39. Blood samples for the determination of phentermine and topiramate concentrations in plasma will be collected at 0 (pre-dose), 1, 2, 3, 4, 5, 7, 10, 16 and 24 hours after the administration of the investigational product(s) on Days 28, 29, 34 and 39. Pre-dose blood samples for determination of the investigational drug concentrations in plasma will be taken in the morning on Days 4 and 33 for metformin; Days 9 and 38 for sitagliptin and Days 27, 33 and 38 for phentermine and topiramate. Semen samples for determination of topiramate concentrations will be collected on Day 28 between five and seven hours after VI-0521 administration in 8 male non-vasectomized subjects to obtain at least 6 evaluable subjects.
The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin.The secondary endpoint is the topiramate concentration in semen.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study population will consist of adult healthy males or females, 19-45 years of age; inclusive who are medically healthy with no clinically significant screening results.
Key exclusion criteria (1 listed)
- Main exclusion criteria include a history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator; any clinically significant laboratory abnormalities as judged by the Investigator; any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure; presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy; any history of a cardiovascular or cerebrovascular event; any active malignancy except basal cell carcinoma; systolic blood pressure > 150 mm Hg or diastolic blood pressure > 95 mm Hg at screening or at check-in (Two rechecks are allowed); positive drug/alcohol test at screening or check in; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing. In female subjects, a positive pregnancy test at screening or check-in is exclusionary.
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 |
|---|---|---|
| Metformin, VI-0521, Sitagliptan, ProbenecidAlso: VI-0521, Sitagliptan, Metformin, ProbenecidThis trial is an open-label, non-randomized, one-sequence crossover study. * metformin 500 mg tablet twice daily on Days 1 to 5 and on Days 30 to 34 * sitagliptan 100 mg tablet once daily on Days 6 to 10 and on Days 35 to 39 * VI-0521 (phentermine/topiramate) capsule once daily each morning at 3.75/23 mg for 2 days (Days 11-12), 7.5/46 mg for 3 days (Days 13-15), 11.25/69 mg for 3 days (Days 16-18) and 15/92 mg for 21 days (Days 19-39) * 2 g (four 500 mg) probenecid tablets on Day 29. | Drug | – |
Primary outcome
The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin.
Time frame: 40 days
1 secondary outcome
The secondary endpoint is the topiramate concentration in semen.
Time frame: 40 days
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 21 Jan 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.
Shiyin Yee study director
VIVUS LLC
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 Metformin, VI-0521, Sitagliptan, Probenecid in people with Obesity, run by VIVUS LLC 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 1 inclusion and 1 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 21 Jan 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?
The primary endpoints of this study will be the PK parameters AUC0-τ and Cmax of phentermine, topiramate, sitagliptin and metformin. (time frame: 40 days). 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 21 Jan 2010.