Approval Probability
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Adjusted LOA
ML Risk
GSK610677 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1 of Cohort-I | EXPERIMENTAL | Subjects in Sequence 1 will receive Placebo during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
| Sequence 2 of Cohort-I | EXPERIMENTAL | Subjects in Sequence 2 will receive 10 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
| Sequence 3 of Cohort-I | EXPERIMENTAL | Subjects in Sequence 3 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. |
| Sequence 4 of Cohort-I | EXPERIMENTAL | Subjects in Sequence 4 will receive 10 microgram GSK610677 during treatment period 1, 50 microgram GSK610677 during treatment period 2 and 250 microgram GSK610677 during treatment period 3. |
| Sequence 5 of Cohort-II | EXPERIMENTAL | Subjects in Sequence 5 will receive Placebo during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
| Sequence 6 of Cohort-II | EXPERIMENTAL | Subjects in Sequence 6 will receive 30 microgram GSK610677 during treatment period 1, Placebo during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
| Sequence 7 of Cohort-II | EXPERIMENTAL | Subjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and Placebo during treatment period 3. |
| Sequence 8 of Cohort-II | EXPERIMENTAL | Subjects in Sequence 7 will receive 30 microgram GSK610677 during treatment period 1, 100 microgram GSK610677 during treatment period 2 and 500 microgram GSK610677 during treatment period 3. |
| Cohort III | EXPERIMENTAL | Subjects in Cohort III after randomization will either receive 1000 microgram GSK610677 or placebo. |
| Name | Type | Description |
|---|---|---|
| GSK610677 | DRUG | GSK610677 Multi-Dose Powder Inhaler will be available in the strength of 10, 50, 100 and 25 microgram with dose levels of 10, 30, 50, 100, 250, 500 and 1000 microgram. Subjects will receive GSK610677 as single inhale dose. |
| Placebo | DRUG | Matching Placebo for GSK610677 will be available as Multi-Dose Powder Inhaler. Subjects will receive Placebo as single inhale dose. |
Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range and determined b...
GSK610677 is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is in Phase 1 clinical development, with a completed single-dose escalation study in healthy male volunteers. The drug is not yet approved and remains under investigation.
GSK610677 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company conducted a Phase 1 first-time-in-human study of the drug in Germany.
GSK610677 is in Phase 1 clinical development. A single-dose escalation study, designed as a first-time-in-human trial, has been completed. The drug is investigational and has not received regulatory approval for any use.
GSK610677 has one completed clinical trial, identified as NCT00694902. This was a Phase 1, single-dose escalation, first-time-in-human study that assessed the safety and tolerability of the drug in 24 healthy male volunteers in Germany.
GSK610677 is the primary identifier for this investigational compound. No alternative names have been established in public clinical trial records. The drug is distinct from other GSK respiratory assets and is being evaluated specifically for chronic obstructive pulmonary disease.