---
title: "To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones."
nct_id: NCT00426608
overall_status: COMPLETED
phase: PHASE1
sponsor: GlaxoSmithKline
study_type: INTERVENTIONAL
primary_condition: Depressive Disorder and Anxiety Disorders
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00426608.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00426608"
ct_last_update_post_date: 2017-09-11
last_seen_at: "2026-05-12T06:01:02.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00426608](https://clinicaltrials.gov/study/NCT00426608)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** GlaxoSmithKline
- **Conditions:** Depressive Disorder and Anxiety Disorders
- **Start Date:** 2006-10-06
- **Completion Date:** 2007-01-08
- **CT.gov Last Update:** 2017-09-11

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion:

* Healthy male subjects
* non-smoker
* normal ECG

Exclusion:

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

## Arms

- **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.
- **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.
- **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.
- **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.
- **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.

## Interventions

- **metyrapone** (DRUG) — Metyrapone will be available as 250 mg dose capsule.
- **alprazolam** (DRUG) — Alprazolam capsules will be available with dose strength of 0.25mg
- **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.
- **GSK561679** (DRUG) — GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.

## Primary Outcomes

- **Blood levels of ACTH: over 24 hours** _(time frame: Over 24 hours)_

## Secondary Outcomes

- **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)_

## Locations (1)

- GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gsk investigational site|cambridge|cambridgeshire|united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00426608.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00426608*  
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