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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01013974 | A Study of GSK573719 in Healthy Japanese Male Subjects | PHASE1 | COMPLETED | 48 | — | — | Oct 5, 2009 | Dec 18, 2009 | Aug 3, 2017 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| GSK573719 250 microgram (μg) arm | EXPERIMENTAL | Each subject will receive the first dose of GSK573719 250 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler. |
| GSK573719 500 μg arm | EXPERIMENTAL | Each subject will receive the first dose of GSK573719 500 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler. |
| GSK573719 1000 μg arm | EXPERIMENTAL | Each subject will receive the first dose of GSK573719 1000 μg on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler. |
| Placebo | PLACEBO_COMPARATOR | Each subject will receive GSK573719 matching placebo on Day 1 followed by once daily dosing for 7 days from Day 4 to Day 10 via a novel dry powder inhaler. |
| Name | Type | Description |
|---|---|---|
| GSK573719 250 μg | DRUG | Strip 1 of the dry powder inhaler will contain GSK573719 250 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation. |
| GSK573719 500 μg | DRUG | Strip 1 of the dry powder inhaler will contain GSK573719 500 μg micronized drug with lactose along with magnesium stearate. Strip 2 will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation. |
| GSK573719 1000 μg | DRUG | Strips 1 and 2 of the dry powder inhaler will contain 500 μg each of GSK573719 micronized drug with lactose along with magnesium stearate. It will be available as dry off white powder for inhalation. |
| GSK573719 matching Placebo | DRUG | Strip 1 and 2 of the dry powder inhaler will contain lactose powder along with magnesium stearate. It will be available as dry off white powder for inhalation. |
Inclusion Criteria: 1. Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other te...