SchizophreniaPhase 1NCT00411866
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
A Phase 1 study testing SB773812 and Ketoconazole in people with Schizophrenia, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with… 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
- Schizophrenia
- What is being tested?
- SB773812 and Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2006to 10 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Body Weight >/=50kg and BMI 18.5-29.9 kg/m2 inclusive
- Normal 12-lead ECG, physical examination and lab screen
Who cannot join
- A history of psychiatric illness,
- A history or presence gastro-intestinal,
- A hepatic or renal disease or orthostatic hypotension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg
The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.
- Conditions
- Schizophrenia
- Being tested
- SB773812, Ketoconazole
- Keywords
- safety, pharmacokinetics,
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB773812Drug
SB-773812 20 mg will be available as white round film coated tablets.
KetoconazoleDrug
Also called SB773812
Ketoconazole will be available as 200mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving ketoconazole for 8 days | Experimental | In Session 1, subjects will receive a single oral dose of SB-773812 20 milligrams (mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 8 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole. Receives: Drug: SB773812; Drug: Ketoconazole |
| Subjects receiving ketoconazole for 14 days | Experimental | In Session 1, subjects will receive a single oral dose of SB-773812 (20mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 12 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole. Receives: Drug: SB773812; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sampling over period of 336 hours post dosing with SB-773812
Measured: over period of 336 hours post dosing
Secondary outcomes (1)
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
Measured: over 48 hours post SB-773812 dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study start13 Oct 2006
- Primary completion10 Oct 2007
- Study completion10 Oct 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00411866
- Sponsor's protocol ID
- NAA105416
- Status last verified
- Aug 2017
- First submitted
- 13 Dec 2006
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg
- ClinicalTrials.gov ID
- NCT00411866
- Acronym / sponsor ID
- NAA105416
- Conditions
- Schizophrenia
- Keywords
- safety, pharmacokinetics,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2006 (actual)
- Primary completion
- 10 Oct 2007 (actual)
- Study completion
- 10 Oct 2007 (actual)
- First posted
- 15 Dec 2006 (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 determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving ketoconazole for 8 days | Experimental | Drug: SB773812, Drug: KetoconazoleIn Session 1, subjects will receive a single oral dose of SB-773812 20 milligrams (mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 8 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole. |
| Subjects receiving ketoconazole for 14 days | Experimental | Drug: SB773812, Drug: KetoconazoleIn Session 1, subjects will receive a single oral dose of SB-773812 (20mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 12 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Body Weight >/=50kg and BMI 18.5-29.9 kg/m2 inclusive
- Normal 12-lead ECG, physical examination and lab screen
Key exclusion criteria (3 listed)
- A history of psychiatric illness,
- A history or presence gastro-intestinal,
- A hepatic or renal disease or orthostatic hypotension.
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 |
|---|---|---|
| SB773812SB-773812 20 mg will be available as white round film coated tablets. | Drug | Subjects receiving ketoconazole for 14 days, Subjects receiving ketoconazole for 8 days |
| KetoconazoleAlso: SB773812Ketoconazole will be available as 200mg tablets. | Drug | Subjects receiving ketoconazole for 14 days, Subjects receiving ketoconazole for 8 days |
Primary outcome
Blood sampling over period of 336 hours post dosing with SB-773812
Time frame: over period of 336 hours post dosing
1 secondary outcome
Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.
Time frame: over 48 hours post SB-773812 dosing.
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 3 Aug 2017.
- Results for study NAA105416 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 SB773812 and Ketoconazole 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 3 inclusion and 3 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 3 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 period of 336 hours post dosing with SB-773812 (time frame: over period of 336 hours post 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 3 Aug 2017.