Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will consist of a screening period, 3 treatment periods and a post-treatment follow-up. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Experimental | Subjects will be randomized to sequence ABC, where A=1 milligram (mg) GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. |
|
| Sequence ACB | Experimental | Subjects will be randomized to sequence ACB, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. |
|
| Sequence BAC | Experimental | Subjects will be randomized to sequence BAC, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. |
|
| Sequence BCA | Experimental | Subjects will be randomized to sequence BCA, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK163090 capsule, fasted | Drug | GSK163090 will be available as 1 mg hard gelatine white/white opaque capsules. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 milliliters (mL) of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters for GSK163090. Pharmacokinetic blood samples will be collected up to 72 hours post-dose following each dosing session. | 72 hours post-dose following each dosing session. |
| Measure | Description | Time Frame |
|---|---|---|
| Additional pharmacokinetic parameters, safety, and tolerability. | 72 hours post-dose following each dosing session. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Neuss | North Rhine-Westphalia | 41460 | Germany |
Not provided
| Label | URL |
|---|---|
| Results for study 103268 can be found on the GSK Clinical Study Register. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C587791 | 1-(3-(2-(4-(2-methyl-5-quinolinyl)-1-piperazinyl)ethyl)phenyl)-2-imidazolidinone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sequence CAB | Experimental | Subjects will be randomized to sequence CAB, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. |
|
| Sequence CBA | Experimental | Subjects will be randomized to sequence CBA, where A=1 mg GSK163090 Capsule, Fasted, B=1 mg GSK163090 Tablet, Fasted and C=1 mg GSK163090 Tablet, Fed. In each of the 3 treatment periods, subjects will receive a single oral dose of GSK163090 in the fed or fasted state, followed by a 7-day wash-out period between each dose. |
|
|
|
| GSK163090 Tablet, fasted | Drug | GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with approximately 240 mL of water. |
|
| GSK163090 Tablet, fed | Drug | GSK163090 will be available as 1 mg white coated round tablet. Each subject will receive a single, oral dose of the study medication on the morning of Day 1. The study drug will be administered with Food and Drug Administration (FDA) high fat breakfast. |
|