Depressive Disorder and Anxiety DisordersPhase 1NCT00426608
To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.
A Phase 1 study testing metyrapone, alprazolam and GSK561679 in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
A study to investigate the effects GSK561679 on part of the body's system that controls the balance of many of the hormones (including cortisol). 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?
- metyrapone, alprazolam and GSK561679
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2006to 8 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 male subjects
- non-smoker
- normal ECG
Who cannot join
- shift workers
- vegetarians
- persons who travel distances
- persons participating in a psychology or psychiatry course
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: Placebo-Controlled, Randomized, Blinded, Double-Dummy, Crossover Study to Investigate the Attenuation of ACTH Activation Induced by Metyrapone With a Single Dose of GSK561679 or Alprazolam in Healthy Volunteers
A study to investigate the effects GSK561679 on part of the body's system that controls the balance of many of the hormones (including cortisol).
- Being tested
- metyrapone, alprazolam, placebo, GSK561679
- Keywords
- HPA axis,, Healthy volunteers, hormones,, GSK561679,, cortisol,
- 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.
metyraponeDrug
Metyrapone will be available as 250 mg dose capsule.
alprazolamDrug
Alprazolam capsules will be available with dose strength of 0.25mg
placeboDrug
GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.
GSK561679Drug
Also called Single dose of GSK561679, Single dose of metyrapone, Single dose of placebo, Single dose of alprazolam
GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Session 1 | Experimental | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 gram per kilogram (g/kg) and Dose 2 of AEBCD sequence. In AEBCD sequence A is placebo, E Alprazolam, B GSK6561679 10 milligram (mg), C GSK6561679 50 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days. Receives: Drug: metyrapone; Drug: alprazolam; Drug: placebo; Drug: GSK561679 |
| Session 2 | Experimental | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of BACED sequence. In BACED sequence B is GSK6561679 10 mg, A placebo, C GSK6561679 50 mg, E Alprazolam, and D GSK6561679 400 mg. Wash-out period will be of 7 days. Receives: Drug: metyrapone; Drug: alprazolam; Drug: placebo; Drug: GSK561679 |
| Session 3 | Experimental | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of CBEAD sequence. In CBEAD sequence C is GSK6561679 50 mg, B GSK6561679 10 mg, E Alprazolam, A placebo, and D GSK6561679 400 mg. Wash-out period will be of 7 days. Receives: Drug: metyrapone; Drug: alprazolam; Drug: placebo; Drug: GSK561679 |
| Session 4 | Experimental | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of ECABD sequence. In ECABD sequence E is Alprazolam, C is GSK6561679 50 mg, A placebo, B GSK6561679 10 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days. Receives: Drug: metyrapone; Drug: alprazolam; Drug: placebo; Drug: GSK561679 |
| Session 5 | Experimental | Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of GSK561679 400 mg and alprazopam placebo. Wash-out period will be of 7 days. Receives: Drug: metyrapone; Drug: alprazolam; Drug: placebo; Drug: GSK561679 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of ACTH: over 24 hours
Measured: Over 24 hours
Secondary outcomes (1)
Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours
Measured: Over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study start6 Oct 2006
- Primary completion8 Jan 2007
- Study completion8 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 20 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
- NCT00426608
- Sponsor's protocol ID
- CRS105511
- Status last verified
- Sep 2017
- First submitted
- 23 Jan 2007
- Last updated
- 11 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Randomized, Blinded, Double-Dummy, Crossover Study to Investigate the Attenuation of ACTH Activation Induced by Metyrapone With a Single Dose of GSK561679 or Alprazolam in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00426608
- Acronym / sponsor ID
- CRS105511
- Keywords
- HPA axis,, Healthy volunteers, hormones,, GSK561679,, cortisol,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2006 (actual)
- Primary completion
- 8 Jan 2007 (actual)
- Study completion
- 8 Jan 2007 (actual)
- First posted
- 25 Jan 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.
A study to investigate the effects GSK561679 on part of the body's system that controls the balance of many of the hormones (including cortisol).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Session 1 | Experimental | Drug: metyrapone, Drug: alprazolam, Drug: placebo, Drug: GSK561679Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 gram per kilogram (g/kg) and Dose 2 of AEBCD sequence. In AEBCD sequence A is placebo, E Alprazolam, B GSK6561679 10 milligram (mg), C GSK6561679 50 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 2 | Experimental | Drug: metyrapone, Drug: alprazolam, Drug: placebo, Drug: GSK561679Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of BACED sequence. In BACED sequence B is GSK6561679 10 mg, A placebo, C GSK6561679 50 mg, E Alprazolam, and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 3 | Experimental | Drug: metyrapone, Drug: alprazolam, Drug: placebo, Drug: GSK561679Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of CBEAD sequence. In CBEAD sequence C is GSK6561679 50 mg, B GSK6561679 10 mg, E Alprazolam, A placebo, and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 4 | Experimental | Drug: metyrapone, Drug: alprazolam, Drug: placebo, Drug: GSK561679Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of ECABD sequence. In ECABD sequence E is Alprazolam, C is GSK6561679 50 mg, A placebo, B GSK6561679 10 mg and D GSK6561679 400 mg. Wash-out period will be of 7 days. |
| Session 5 | Experimental | Drug: metyrapone, Drug: alprazolam, Drug: placebo, Drug: GSK561679Subjects will be randomized to receive Dose 1 of Metyrapone 0.04 g/kg and Dose 2 of GSK561679 400 mg and alprazopam placebo. Wash-out period will be of 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects
- non-smoker
- normal ECG
Key exclusion criteria (4 listed)
- shift workers
- vegetarians
- persons who travel distances
- persons participating in a psychology or psychiatry course
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 |
|---|---|---|
| metyraponeMetyrapone will be available as 250 mg dose capsule. | Drug | Session 1, Session 2, Session 3, Session 4, Session 5 |
| alprazolamAlprazolam capsules will be available with dose strength of 0.25mg | Drug | Session 1, Session 2, Session 3, Session 4, Session 5 |
| placeboGSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules. | Drug | Session 1, Session 2, Session 3, Session 4, Session 5 |
| GSK561679Also: Single dose of GSK561679, Single dose of metyrapone, Single dose of placebo, Single dose of alprazolamGSK561679 tablets will be available with dose strength of 50, 10 and 200 mg. | Drug | Session 1, Session 2, Session 3, Session 4, Session 5 |
Primary outcome
Blood levels of ACTH: over 24 hours
Time frame: Over 24 hours
1 secondary outcome
Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours
Time frame: Over 24 hours
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 Sep 2017.
- Results for study CRS105511 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 metyrapone, alprazolam and GSK561679 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 3 inclusion and 4 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 Sep 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 levels of ACTH: over 24 hours (time frame: Over 24 hours). 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 Sep 2017.