To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

metyrapone

alprazolam

placebo

GSK561679

About this trial

This is an interventional diagnostic trial for Depressive Disorder and Anxiety Disorders focused on measuring HPA axis,, Healthy volunteers, hormones,, GSK561679,, cortisol,

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion:

Healthy male subjects
non-smoker
normal ECG

Exclusion:

shift workers
vegetarians
persons who travel distances
persons participating in a psychology or psychiatry course

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Session 1

Session 2

Session 3

Session 4

Session 5

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Blood levels of ACTH: over 24 hours

Secondary Outcome Measures

Blood levels of GSK561679, metyrapone, alprazolam, cortisol: over 24 hours Questionnaires: each visit Safety (ECG/vital signs/Adverse Events/ laboratory): over 24 hours

Full Information

NCT ID

NCT00426608

First Posted

January 23, 2007

Last Updated

September 7, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00426608

Brief Title

To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

October 6, 2006 (Actual)

Primary Completion Date

January 8, 2007 (Actual)

Study Completion Date

January 8, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder and Anxiety Disorders

Keywords

HPA axis,, Healthy volunteers, hormones,, GSK561679,, cortisol,

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Session 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Session 2

Arm Type

Experimental

Arm Description

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.

Arm Title

Session 3

Arm Type

Experimental

Arm Description

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.

Arm Title

Session 4

Arm Type

Experimental

Arm Description

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.

Arm Title

Session 5

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

metyrapone

Intervention Description

Metyrapone will be available as 250 mg dose capsule.

Intervention Type

Drug

Intervention Name(s)

alprazolam

Intervention Description

Alprazolam capsules will be available with dose strength of 0.25mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.

Intervention Type

Drug

Intervention Name(s)

GSK561679

Other Intervention Name(s)

Single dose of GSK561679, Single dose of metyrapone, Single dose of placebo, Single dose of alprazolam

Intervention Description

GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

Primary Outcome Measure Information:

Title

Blood levels of ACTH: over 24 hours

Time Frame

Over 24 hours

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: Healthy male subjects non-smoker normal ECG Exclusion: shift workers vegetarians persons who travel distances persons participating in a psychology or psychiatry course

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Depressive Disorder and Anxiety Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial