Healthy SubjectsPhase 1NCT00488098
GSK372475 Bioequivalence Study
A Phase 1 study testing GSK372475 in people with Healthy Subjects and Depressive Disorder, run by GlaxoSmithKline at 1 site in Canada.
Trial summary
The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Depressive Disorder
- What is being tested?
- GSK372475
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to not given
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males/Females aged 18-45 years
- Non-smokers
- BMI 19-30 kg.m2
- QTc<450msec
Who cannot join
- Use of oral contraception
- Positive breath alcohol and drug screen
- Regular alcohol consumption
- Current psychiatric illness or within 1 year.
- History of GI, hepatic or renal disease
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.
The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
- Conditions
- Healthy Subjects, Depressive Disorder
- Being tested
- GSK372475
- Keywords
- Healthy Bioequivalence
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK372475Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
Measured: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
Secondary outcomes (3)
Adverse events
Measured: all visits
vitals (all visits) + ECG
Measured: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
labs
Measured: at screening and 2 weeks post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488098
- Sponsor's protocol ID
- SND110117
- Status last verified
- Feb 2011
- First submitted
- 15 Jun 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00488098
- Acronym / sponsor ID
- SND110117
- Conditions
- Healthy Subjects, Depressive Disorder
- Keywords
- Healthy Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- First posted
- 19 Jun 2007 (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 study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Males/Females aged 18-45 years
- Non-smokers
- BMI 19-30 kg.m2
- QTc<450msec
Key exclusion criteria (6 listed)
- Use of oral contraception
- Positive breath alcohol and drug screen
- Regular alcohol consumption
- Current psychiatric illness or within 1 year.
- History of GI, hepatic or renal disease
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 |
|---|---|---|
| GSK372475 | Drug | – |
Primary outcome
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax
Time frame: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
3 secondary outcomes
Adverse events
Time frame: all visits
vitals (all visits) + ECG
Time frame: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
labs
Time frame: at screening and 2 weeks post dose
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 4 Jun 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 GSK372475 in people with Healthy Subjects and Depressive Disorder, run by GlaxoSmithKline at 1 site in Canada.
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 6 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 4 Jun 2012. 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 Canada. 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?
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax (time frame: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.). 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 4 Jun 2012.