SchizophreniaPhase 1NCT00500201
A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets.
A Phase 1 study testing SB- 773812 60 mg and SB- 773812 120 mg in people with Schizophrenia, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SB- 773812 60 mg and SB- 773812 120 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2007to 25 Jul 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
- be a healthy man or woman, aged 18 to 55, and be neither too fat nor too thin;
- If you are a woman who can have a baby, you must use an acceptable method of contraception, from the start of your last period before you take the study medicine, until you've had your first normal period after the end of the study. You might need to use contraception for longer than that. You don't need to use contraception if your partner has been sterilized (had an operation to cut the tubes that carry sperm).
- Acceptable methods of contraception for women are:
- Diaphragm or cap and condom with spermicide;
- the 'Pill' and condom with spermicide - you must have been taking the 'Pill' for at least 3 months before the start of the study;
- Intrauterine device (IUD or 'coil' - your GP must confirm that you have one) and condom with spermicide; or
Show all 16Show fewer
- Condom and spermicide only, if you're a woman who has had an operation to have your tubes tied.
- If you are a woman who CANNOT have a baby, you should have gone through menopause at least 1 year ago;
- had your womb removed; or
- had both ovaries removed.
- have normal physical exam
- have normal blood pressure and pulse.
- be able to swallow tablets;
- show proof of identity - we'll tell you what's suitable.
- have the ability to understand and comply with protocol requirements, instructions and restrictions.
- be available to attend the ward for repeat tests, if necessary, during the 2 weeks after your final planned visit.
Who cannot join
- abuse alcohol or drugs;
- drink, on average, more than 3 units of alcohol daily if you're a man, or 2 units if you're a woman (1 unit = ½ pint of beer, 1 small glass of wine or 1 measure of spirits);
- have been a blood donor in the last 3 months;
- have been given an experimental medicine in the last 3 months;
- have taken part in a study of an experimental medicine in the last 3 months;
- be a smoker, or have smoked cigarettes or used other tobacco products regularly in the last 6 months - we may test your breath for smoking at any time during the study;
Show all 14Show fewer
- be pregnant or breast feeding;
- have had a serious reaction to any medicine;
- have any screening test results that show you're not suitable, even if they don't mean that you're unhealthy;
- have had any important illness (including diabetes and asthma) that, in the opinion of the study doctor, makes you unsuitable for the study;
- have had any mental illnesses;
- suffer from numbness or tingling in your arms, legs, hands or feet; or
- has had glaucoma (increased pressure inside the eye).
- You may not be able to take part if you've taken any medicines recently, including herbal remedies like St John's wort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Blind, Double Dummy, Placebo Controlled, Randomized, 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers
Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients. The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.
- Conditions
- Schizophrenia
- Being tested
- SB- 773812 60 mg, SB- 773812 120 mg, Placebo
- Keywords
- Healthy Volunteer
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB- 773812 60 mgDrug
Also called SB- 773812
SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
SB- 773812 120 mgDrug
SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
PlaceboDrug
Placebo tablets will be administered orally by subjects.
| Study group | Role | What they receive |
|---|---|---|
| Subjects in treatment sequence AB | Experimental | In treatment sequence AB first subjects will be randomized to receive treatment A (two tablets of 60 milligram [mg] of SB-773812) and one placebo tablet. Then subjects will receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets . There will be a wash-out period of 20 days between. Receives: Drug: SB- 773812 60 mg; Drug: SB- 773812 120 mg; Drug: Placebo |
| Subjects in treatment sequence BA | Experimental | In treatment sequence BA first subjects will be randomized to receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets. Then subjects will receive treatment A (two tablets of 60 mg of SB-773812) and one placebo tablet. There will be a wash-out period of 20 days between. Receives: Drug: SB- 773812 60 mg; Drug: SB- 773812 120 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions.
Measured: 336 hrs post SB773812 dosing
Secondary outcomes (2)
Safety: ECG, vital signs, clinical labs over 336 hours post SB-773812 dosing in both dosing sessions.
Measured: 336 hours post SB-773812 dosing
Continuous adverse event monitoring from dosing until study conclusion and follow up, 7-14days after last dose.
Measured: 7-14days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study start24 May 2007
- Primary completion25 Jul 2007
- Study completion25 Jul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Crossover
- Enrolment
- 18 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
- NCT00500201
- Sponsor's protocol ID
- NAA105737
- Status last verified
- Aug 2017
- First submitted
- 10 Jul 2007
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Double Dummy, Placebo Controlled, Randomized, 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00500201
- Acronym / sponsor ID
- NAA105737
- Conditions
- Schizophrenia
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 May 2007 (actual)
- Primary completion
- 25 Jul 2007 (actual)
- Study completion
- 25 Jul 2007 (actual)
- First posted
- 12 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.
Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients. The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects in treatment sequence AB | Experimental | Drug: SB- 773812 60 mg, Drug: SB- 773812 120 mg, Drug: PlaceboIn treatment sequence AB first subjects will be randomized to receive treatment A (two tablets of 60 milligram [mg] of SB-773812) and one placebo tablet. Then subjects will receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets . There will be a wash-out period of 20 days between. |
| Subjects in treatment sequence BA | Experimental | Drug: SB- 773812 60 mg, Drug: SB- 773812 120 mg, Drug: PlaceboIn treatment sequence BA first subjects will be randomized to receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets. Then subjects will receive treatment A (two tablets of 60 mg of SB-773812) and one placebo tablet. There will be a wash-out period of 20 days between. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- be a healthy man or woman, aged 18 to 55, and be neither too fat nor too thin;
- If you are a woman who can have a baby, you must use an acceptable method of contraception, from the start of your last period before you take the study medicine, until you've had your first normal period after the end of the study. You might need to use contraception for longer than that. You don't need to use contraception if your partner has been sterilized (had an operation to cut the tubes that carry sperm).
- Acceptable methods of contraception for women are:
- Diaphragm or cap and condom with spermicide;
- the 'Pill' and condom with spermicide - you must have been taking the 'Pill' for at least 3 months before the start of the study;
Key exclusion criteria (14 listed)
- abuse alcohol or drugs;
- drink, on average, more than 3 units of alcohol daily if you're a man, or 2 units if you're a woman (1 unit = ½ pint of beer, 1 small glass of wine or 1 measure of spirits);
- have been a blood donor in the last 3 months;
- have been given an experimental medicine in the last 3 months;
- have taken part in a study of an experimental medicine in the last 3 months;
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 |
|---|---|---|
| SB- 773812 60 mgAlso: SB- 773812SB- 773812 will be available dose strength of 60 mg and administered orally by subjects. | Drug | Subjects in treatment sequence AB, Subjects in treatment sequence BA |
| SB- 773812 120 mgSB- 773812 will be available dose strength of 120 mg and administered orally by subjects. | Drug | Subjects in treatment sequence AB, Subjects in treatment sequence BA |
| PlaceboPlacebo tablets will be administered orally by subjects. | Drug | Subjects in treatment sequence AB, Subjects in treatment sequence BA |
Primary outcome
Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions.
Time frame: 336 hrs post SB773812 dosing
2 secondary outcomes
Safety: ECG, vital signs, clinical labs over 336 hours post SB-773812 dosing in both dosing sessions.
Time frame: 336 hours post SB-773812 dosing
Continuous adverse event monitoring from dosing until study conclusion and follow up, 7-14days after last dose.
Time frame: 7-14days after last 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 8 Aug 2017.
- Results for study NAA105737 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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 SB- 773812 60 mg and SB- 773812 120 mg in people with Schizophrenia, 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 16 inclusion and 14 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 8 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?
Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions. (time frame: 336 hrs post SB773812 dosing). 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 8 Aug 2017.