Bipolar DisorderPhase 1NCT00501865
Study to Assess the Effect of Food on the Concentration of GW273225 in the Body of Healthy Male and Female Volunteers
A Phase 1 study testing GW273225 in people with Bipolar Disorder, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The rationale of this study is to assess whether or not food affects the absorption of GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or not this drug should be given at a certain time relative to the consumption of food. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- GW273225
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2007to 11 Oct 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 18-55 years, inclusive.
- Body weight 45-100kg and BMI 19-29.9 kg/m2 inclusive.
- Post-menopausal females (longer than two years). Or Pre-menopausal females with a documented hysterectomy and/or bilateral oophorectomy, the latter only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Female subjects of child bearing potential willing to participate commit to use a double-barrier method of contraception. One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective, otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository): Documented tubal ligation. Documented placement of an IUD or IUS. Male partner sterilisation prior to the female subject's entry into the study and is the sole partner for that female subject.
- No abnormality on relevant clinical examination or clinical chemistry or haematology examination at the pre-study medical examination.
- A normal 12-lead ECG at the pre-study medical examination
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- A negative pre-study Hepatitis B, Hepatitis C, and HIV antibody result at screening.
- A negative pre-study urine drug screen.
- A negative screen for alcohol.
- Subjects must smoke <10 cigarettes per day.
- The subject is able to understand and comply with the study and it's restrictions.
Who cannot join
- An unwillingness of the male subject to use a double-barrier method of contraception.
- Female subject is pregnant or lactating.
- Female subjects using hormonal contraceptive precautions including progesterone-coated IUD and oral contraceptives.
- Female subjects using hormonal replacement therapy.
- History of alcohol/drug abuse or dependence within 12 months of the study
- The subject has a positive pre-study urine drug/ urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
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- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Weekly alcohol intake of more than 21 units or an average daily intake of greater than three units (for male subjects) or weekly alcohol intake more than 14 units or an average daily intake of greater than two units (for female subjects).
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- History of sensitivity to any of the study medications, or components thereof.
- Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
- History of hypersensitivity to lamotrigine or GW273225.
- History of clinically relevant skin rashes and allergies that, in the opinion of the investigator, might interfere with the conduct of the study.
- Subject has current or past history of seizure disorder or brain injury, or any condition which, in the opinion of the investigator, predisposes to seizure; subject treated with other medications or treatment regimens that lower seizure threshold; subject undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB3 7TR
About this study
Official title: An Open, Randomised, Two-period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of GW273225 Administered Immediately After Food and Administered in Fasted State to Healthy Male and Female Subjects
The rationale of this study is to assess whether or not food affects the absorption of GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or not this drug should be given at a certain time relative to the consumption of food.
- Conditions
- Bipolar Disorder
- Being tested
- GW273225
- Keywords
- healthy volunteers, food effect,, quantitative pharmacokinetic analysis,, GW273225,
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW273225Drug
GW273225 will be available as white tablets containing 25 mg GW273225.The study drug will be taken with 240 milliliters of water at room temperature.
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Subjects will be randomized to sequence AB, where A represents fasted state and B represents fed state. Subjects will be administered a single oral dose of GW273225 50 milligrams (mg) in the fasted state in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 2. There will be at least 21 days between doses for the fasted and fed treatment phases of the study. Receives: Drug: GW273225 |
| Sequence BA | Experimental | Subjects will be randomized to sequence BA, where A represents fasted state and B represents fed state. Subjects will be orally administered a single dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg in the fasted state in dosing period 2. There will be at least 21 days between doses for the fed and fasted treatment phases of the study. Receives: Drug: GW273225 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability and maximal concentration of the drug measured between 0 hours and 216 hours post dose.
Measured: measured between 0 hours and 216 hours post dose
Secondary outcomes (1)
Time to maximal concentration measured between 0-216h post dose. Clinically relevant changes from baseline in clinical laboratory parameters (48 hours post dose), ECGs (0-48h post dose) and vital signs (0-48 hours post dose and any AEs during the study.
Measured: Time to maximal concentration measured between 0-216h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study start6 Aug 2007
- Primary completion11 Oct 2007
- Study completion11 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT00501865
- Sponsor's protocol ID
- NAP109169
- Status last verified
- Aug 2017
- First submitted
- 13 Jul 2007
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Two-period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of GW273225 Administered Immediately After Food and Administered in Fasted State to Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00501865
- Acronym / sponsor ID
- NAP109169
- Conditions
- Bipolar Disorder
- Keywords
- healthy volunteers, food effect,, quantitative pharmacokinetic analysis,, GW273225,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2007 (actual)
- Primary completion
- 11 Oct 2007 (actual)
- Study completion
- 11 Oct 2007 (actual)
- First posted
- 16 Jul 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 rationale of this study is to assess whether or not food affects the absorption of GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or not this drug should be given at a certain time relative to the consumption of food.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: GW273225Subjects will be randomized to sequence AB, where A represents fasted state and B represents fed state. Subjects will be administered a single oral dose of GW273225 50 milligrams (mg) in the fasted state in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 2. There will be at least 21 days between doses for the fasted and fed treatment phases of the study. |
| Sequence BA | Experimental | Drug: GW273225Subjects will be randomized to sequence BA, where A represents fasted state and B represents fed state. Subjects will be orally administered a single dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg in the fasted state in dosing period 2. There will be at least 21 days between doses for the fed and fasted treatment phases of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male or female subjects aged 18-55 years, inclusive.
- Body weight 45-100kg and BMI 19-29.9 kg/m2 inclusive.
- Post-menopausal females (longer than two years). Or Pre-menopausal females with a documented hysterectomy and/or bilateral oophorectomy, the latter only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Female subjects of child bearing potential willing to participate commit to use a double-barrier method of contraception. One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective, otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository): Documented tubal ligation. Documented placement of an IUD or IUS. Male partner sterilisation prior to the female subject's entry into the study and is the sole partner for that female subject.
- No abnormality on relevant clinical examination or clinical chemistry or haematology examination at the pre-study medical examination.
Key exclusion criteria (16 listed)
- An unwillingness of the male subject to use a double-barrier method of contraception.
- Female subject is pregnant or lactating.
- Female subjects using hormonal contraceptive precautions including progesterone-coated IUD and oral contraceptives.
- Female subjects using hormonal replacement therapy.
- History of alcohol/drug abuse or dependence within 12 months of the study
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 |
|---|---|---|
| GW273225GW273225 will be available as white tablets containing 25 mg GW273225.The study drug will be taken with 240 milliliters of water at room temperature. | Drug | Sequence AB, Sequence BA |
Primary outcome
Bioavailability and maximal concentration of the drug measured between 0 hours and 216 hours post dose.
Time frame: measured between 0 hours and 216 hours post dose
1 secondary outcome
Time to maximal concentration measured between 0-216h post dose. Clinically relevant changes from baseline in clinical laboratory parameters (48 hours post dose), ECGs (0-48h post dose) and vital signs (0-48 hours post dose and any AEs during the study.
Time frame: Time to maximal concentration measured between 0-216h 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 Aug 2017.
- Results for study 109169 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 GW273225 in people with Bipolar Disorder, run by GlaxoSmithKline 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 11 inclusion and 16 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 Aug 2017. 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?
Bioavailability and maximal concentration of the drug measured between 0 hours and 216 hours post dose. (time frame: measured between 0 hours and 216 hours 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 Aug 2017.