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

NCT00426608 | Completed Phase 1

• 1 other identifier: CRS105511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Depressive Disorder and Anxiety Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Blood levels of ACTH: over 24 hours

  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

  Over 24 hours

Study Arms (5)

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.

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.

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.

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.

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.

Drug: metyrapone; Drug: alprazolam; Drug: placebo; Drug: GSK561679

Interventions

metyrapone DRUG

Metyrapone will be available as 250 mg dose capsule.

Session 1; Session 2; Session 3; Session 4; Session 5

alprazolam DRUG

Alprazolam capsules will be available with dose strength of 0.25mg

Session 1; Session 2; Session 3; Session 4; Session 5

placebo DRUG

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

Session 1; Session 2; Session 3; Session 4; Session 5

GSK561679 DRUG

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

Also known as: Single dose of GSK561679, Single dose of metyrapone, Single dose of placebo, Single dose of alprazolam

Session 1; Session 2; Session 3; Session 4; Session 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects
• non-smoker
• normal ECG

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Links

• Results for study CRS105511 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Interventions

Metyrapone; Alprazolam; NBI 77860

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 25, 2007
• Study Start: October 6, 2006
• Primary Completion: January 8, 2007
• Study Completion: January 8, 2007
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

GB (1)