Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK233705 · 9 trials · 1 indication
Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value).
The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose \[time 0\] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Arm 3 | EXPERIMENTAL | GSK233705 50mcg |
| Arm 4 | EXPERIMENTAL | GSK233705 100mcg |
| Arm 5 | EXPERIMENTAL | GSK233705 200mcg |
| Arm 6 | PLACEBO_COMPARATOR | Placebo |
| Long acting muscarinic receptor antagonist (LAMA) | EXPERIMENTAL | Inhaled Long acting muscarinic receptor antagonist (LAMA which is in development as a treatment for Chronic Obstructive Pulmonary Disease. |
| Long acting Beta 2 agonist (LABA) | EXPERIMENTAL | Inhaled Long Acting Beta 2 agonist (LABA) which is in development as a treatment for Chronic Obstructive Pulmonary Disease. |
| LAMA with LABA | EXPERIMENTAL | Inhaled Long Acting Muscarinic receptor Antagonist (LAMA) and a inhaled Long Acting Beta 2 Agonist (LABA), both in development for treatment of Chronic Obstructive Pulmonary Disease and taken in combination. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, no intervention. |
| LAMA | EXPERIMENTAL | After randomization subject will inhale either GSK233705 50, 100 or 200 microgram once daily for 7 days. |
| Period 1 | EXPERIMENTAL | Subjects will receive first placebo, then GSK233705, GW642444 and combination of GSK233705 and GW642444 |
| Period 2 | EXPERIMENTAL | Subjects will receive first combination of GSK233705 and GW642444, then placebo, GSK233705 and GW642444 |
| Period 3 | EXPERIMENTAL | Subjects will receive first GSK233705, then GW642444, combination of GSK233705 and GW642444 and later placebo |
| Period 4 | EXPERIMENTAL | Subjects will receive first GW642444, then combination of GSK233705 and GW642444, placebo, and later GSK233705 |
| Subjects receiving GSK233705 | EXPERIMENTAL | Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points. |
| Subjects receiving treatment sequence 1 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 1; GSK233705 20 micrograms, GSK233705 100 micrograms, tiotropium and placebo. |
| Subjects receiving treatment sequence 2 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 2; GSK233705 20 micrograms, Placebo, GSK233705 50 micrograms and tiotropium. |
| Subjects receiving treatment sequence 3 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 3; GSK233705 20 micrograms, tiotropium, Placebo and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 4 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 4; GSK233705 20 micrograms, placebo, tiotropium and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 5 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 5; Placebo, tiotropium, GSK233705 20 micrograms and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 6 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 6; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and tiotropium. |
| Subjects receiving treatment sequence 7 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 7; tiotropium, GSK233705 20 micrograms, GSK233705 50 micrograms and Placebo. |
| Subjects receiving treatment sequence 8 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 8; tiotropium, GSK233705 20 micrograms, Placebo and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 9 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 9; GSK233705 20 micrograms, tiotropium, GSK233705 50 micrograms and Placebo. |
| Subjects receiving treatment sequence 10 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 10; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and tiotropium. |
| Subjects receiving treatment sequence 11 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 11; Placebo, GSK233705 20 micrograms, tiotropium, and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 12 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 12; Tiotropium, Placebo, GSK233705 20 micrograms and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 13 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 13; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and GSK233705 100 micrograms. |
| Subjects receiving treatment sequence 14 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 14; GSK233705 20 micrograms, placebo, GSK233705 50 micrograms and GSK233705 100 micrograms. |
| Subjects receiving treatment sequence 15 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 15; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and GSK233705 50 micrograms. |
| Subjects receiving treatment sequence 16 | EXPERIMENTAL | Eligible subjects will receive treatment sequence 16; GSK233705 20 micrograms, GSK233705 100 micrograms, GSK233705 50 micrograms and Placebo. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | matching placebo |
| GSK233705/GW642444 | DRUG | The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler. |
| GSK233705 12.5mcg | DRUG | Once daily via dry powder inhaler |
| GSK233705 25mcg | DRUG | once daily via dry powder inhaler |
| GSK233705 50mcg | DRUG | Once daily via dry powder inhaler |
| GSK233705 100mcg | DRUG | Once daily via dry powder inhaler |
| GSK233705 200mcg | DRUG | Once daily via dry powder inhaler |
| GSK233705 | DRUG | - |
| GSK233705 and GW642444 | DRUG | Inhaled Long acting muscarinic receptor antagonist (LAMA) and a inhaled Long acting Beta 2 agonist (LABA) both in development as treatment for Chronic Obstructive Pulmonary Disease, taken in combination. |
| GW642444 | DRUG | Inhaled Long acting Beta 2 agonist (LABA) |
| Tiotropium | DRUG | Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device. |
Inclusion Criteria: * male and females 40 to 80 years of age (inclusive) * COPD diagnosis * Current or previous smokers with a cigarette smoking history of at least 10 pack- * Post-albuterol FEV1/FVC of 0.70 or less * Post-albuterol FEV1 of 35% to 80% (inclusive) Exclusion Criteria: * Pregnant or...
GSK233705 is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is in Phase 2 clinical development, though all nine completed trials to date have been Phase 1 studies. The drug is administered via inhalation and has been studied in both healthy volunteers and COPD patients.
GSK233705 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company has sponsored nine clinical trials of the drug, all of which are now completed, with a total enrollment of 794 participants across multiple countries.
GSK233705 is in Phase 2 clinical development for chronic obstructive pulmonary disease. However, all nine clinical trials listed for the drug are Phase 1 studies that have been completed. The drug is investigational and has not been approved by regulatory authorities.
GSK233705 has been studied in nine completed clinical trials, including NCT00279019, a safety study with tiotropium in COPD patients in Germany, and NCT00453687, a safety and tolerability study in healthy male volunteers in the United States. Other trials include NCT00783003 and NCT00964405, which assessed safety and pharmacokinetics in healthy subjects.
No, GSK233705 and GW642444 are different investigational drugs. They were studied together in a Phase 1 trial (NCT00783003) that assessed the safety and pharmacokinetics of inhaled doses of both compounds in healthy subjects in the United Kingdom. GSK233705 is being developed for COPD, while GW642444 is a separate molecule.