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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00694902 | Single Dose Escalation Study FTIM in Order to Assess Safety and Tolerability of GSK610677 | PHASE1 | COMPLETED | 24 | — | — | May 26, 2008 | Sep 23, 2008 | Aug 10, 2017 | 1 | Germany |
| 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...