Type 2 Diabetes MellitusPhase 1NCT00924430
Interaction Study SLV337/Simvastatin
A Phase 1 study testing Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin and Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin in people with Type 2 Diabetes Mellitus, run by Solvay Pharmaceuticals at 1 site in United Kingdom.
Trial summary
To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects 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
- Type 2 Diabetes Mellitus
- What is being tested?
- Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin and Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Jul 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers with Body Mass Index 18.0-28.0 kg/m2
Who cannot join
- Clinically relevant medical history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Drug Interaction Study to Investigate the Effects of SLV337 on the Pharmacokinetics of Simvastatin and Simvastatin Acid in Healthy Male Volunteers
To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin, Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin
- Keywords
- Interaction SLV337 and simvastatin, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ SimvastatinDrug
Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 beta capsule, single dose of 1400 mg SLV337 alpha capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day
Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ SimvastatinDrug
Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 alpha capsule, single dose of 1400 mg SLV337 beta capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin |
| 2 | Other | Not described Receives: Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only
Measured: 20 days
Secondary outcomes (2)
SLV337 and its acylglucuronide metabolite: Cmax, tmax, AUC0-24, AUC0-t, CL/F (SLV337 only) on Days 1 and 13, as well as AUC, lz, t1/2 and Vz/F (SLV337 only) on Day 1
Measured: 20 days
Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs
Measured: During the duration of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924430
- Sponsor's protocol ID
- S337.1.002
- Other IDs
- 2009-010392-24, 2009
- Status last verified
- Sep 2009
- First submitted
- 19 May 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug Interaction Study to Investigate the Effects of SLV337 on the Pharmacokinetics of Simvastatin and Simvastatin Acid in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00924430
- Acronym / sponsor ID
- S337.1.002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Interaction SLV337 and simvastatin, Type 2 diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Jun 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.
To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin |
| 2 | Other | Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers with Body Mass Index 18.0-28.0 kg/m2
Key exclusion criteria (1 listed)
- Clinically relevant medical history
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 |
|---|---|---|
| Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ SimvastatinSingle dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 beta capsule, single dose of 1400 mg SLV337 alpha capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day | Drug | 1 |
| Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ SimvastatinSingle dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 alpha capsule, single dose of 1400 mg SLV337 beta capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day | Drug | 2 |
Primary outcome
Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only
Time frame: 20 days
2 secondary outcomes
SLV337 and its acylglucuronide metabolite: Cmax, tmax, AUC0-24, AUC0-t, CL/F (SLV337 only) on Days 1 and 13, as well as AUC, lz, t1/2 and Vz/F (SLV337 only) on Day 1
Time frame: 20 days
Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs
Time frame: During the duration of study participation
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 9 Sep 2009.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
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 Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin and Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin in people with Type 2 Diabetes Mellitus, run by Solvay Pharmaceuticals 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 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 9 Sep 2009. 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?
Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only (time frame: 20 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 9 Sep 2009.