Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00426608 | To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones. | PHASE1 | COMPLETED | 20 | — | — | Oct 6, 2006 | Jan 8, 2007 | Sep 11, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion: * Healthy male subjects * non-smoker * normal ECG Exclusion: * shift workers * vegetarians * persons who travel distances * persons participating in a psychology or psychiatry course