Depressive Disorder and Anxiety DisordersPhase 1NCT01059591
First Study in Humans With GSK424887
A Phase 1 study testing GSK424887 and PET in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder and Anxiety Disorders
- What is being tested?
- GSK424887 and PET
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 May 2006to 25 Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged 18-45 years, limited to 25-40 years for PET section
Who cannot join
- The subject has a positive: drug/alcohol, Hepatitis, HIV screen
- The subject has a history of psychiatric illness suicidal attempts or behaviour.
- Abuse of alcohol.
- Clinically significant laboratory, ECG abnormality;
- The subject has recently received an investigational.
- Use of prescription or non-prescription drugs,
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- History or presence of allergy to the study drug or drugs of this class,.
- Donation of more than 500 mL blood within the 90 days before dosing.
- An unwillingness of male subjects to comply with contraceptive requirements
- Average daily caffeine intake exceeding Protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK424887 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin- Receceptor Occupancy
This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology
- Being tested
- GSK424887, Placebo, PET
- Keywords
- NK1 antagonist and SSRI, Healthy subjects, Safety, First time in Human
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK424887Drug
GSK424887 2mg, 10mg, 50mg, 100mg capsule
PlaceboDrug
Placebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule
PETRadiation
Each subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | GSK424887 once daily Receives: Drug: GSK424887; Radiation: PET |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax
Measured: 12 weeks
Secondary outcomes (1)
Brain receptor occupancy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study start25 May 2006
- Primary completion25 Jan 2007
- Study completion25 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder and Anxiety DisordersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 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
- NCT01059591
- Sponsor's protocol ID
- 105011
- Status last verified
- Aug 2017
- First submitted
- 28 Jan 2010
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK424887 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin- Receceptor Occupancy
- ClinicalTrials.gov ID
- NCT01059591
- Acronym / sponsor ID
- 105011
- Keywords
- NK1 antagonist and SSRI, Healthy subjects, Safety, First time in Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 May 2006 (actual)
- Primary completion
- 25 Jan 2007 (actual)
- Study completion
- 25 Jan 2007 (actual)
- First posted
- 1 Feb 2010 (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.
This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: GSK424887, Radiation: PETGSK424887 once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males aged 18-45 years, limited to 25-40 years for PET section
Key exclusion criteria (10 listed)
- The subject has a positive: drug/alcohol, Hepatitis, HIV screen
- The subject has a history of psychiatric illness suicidal attempts or behaviour.
- Abuse of alcohol.
- Clinically significant laboratory, ECG abnormality;
- The subject has recently received an investigational.
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 |
|---|---|---|
| GSK424887GSK424887 2mg, 10mg, 50mg, 100mg capsule | Drug | Active |
| PlaceboPlacebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule | Drug | Placebo |
| PETEach subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose | Radiation | Active |
Primary outcome
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax
Time frame: 12 weeks
1 secondary outcome
Brain receptor occupancy
Time frame: 2 weeks
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 11 Aug 2017.
- Results for study 105011 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 GSK424887 and PET in people with Depressive Disorder and Anxiety Disorders, 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 1 inclusion and 10 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 11 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. Some participants in this study may receive a placebo. 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?
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax (time frame: 12 weeks). 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 11 Aug 2017.