Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK573719 250 μg · 1 trial · 1 indication
| 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...
GSK573719 250 μg is an investigational small molecule being studied for chronic obstructive pulmonary disease (COPD). It is in Phase 1 clinical development and has been evaluated in a completed clinical trial involving healthy volunteers.
GSK573719 250 μg is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for chronic obstructive pulmonary disease.
GSK573719 250 μg is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial for this drug has been completed.
GSK573719 250 μg has been studied in one completed Phase 1 clinical trial, identified as NCT01013974. This trial, titled 'A Study of GSK573719 in Healthy Japanese Male Subjects,' enrolled 48 participants and was conducted in Japan.
Yes, the completed Phase 1 clinical trial of GSK573719 250 μg (NCT01013974) was randomized, double-blind, and placebo-controlled. The trial enrolled 48 healthy Japanese male subjects aged 20 years and older.