Approval Probability
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ML Risk
GSK2239633 · 2 trials · 1 indication
adverse events and clinically relevant changes in safety parameters - 12-lead ECG, telemetry, vital signs (systolic and diastolic blood pressure, heart rate, temperature), clinical laboratory data (haematology, clinical chemistry, urinalysis).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Interlocking design with Cohort 2. Single dose; treatment period over 2 days such that one subject will receive GSK2239633 and one subject will receive placebo on Day 1. The remaining subjects will be dosed on day 2 of each treatment period assuming adequate safety from Day 1. Placebo and an escalation of GSK2239633 from 150mg, to 600mg, to 1200mg and 1200mg with a FDA high fat/high calorie meal, will be administered over the 13 week long study allowing adequate washout period between doses. |
| Cohort 2 | EXPERIMENTAL | Interlocking design with Cohort 1. Single dose; treatment period over 2 days such that one subject will receive GSK2239633 and one subject will receive placebo on Day 1. The remaining subjects will be dosed on day 2 of each treatment period assuming adequate safety from Day 1. Placebo and an escalation of GSK2239633 from 300mg, to 900mg, and 1500mg, will be administered over the 13 week long study allowing adequate washout period between doses. |
| GSK2239633 | EXPERIMENTAL | Single dose infusion of study drug over 15 minutes |
| Name | Type | Description |
|---|---|---|
| GSK2239633 | DRUG | Drug will be orally administered at the doses and time points detailed in the 'arms' section. |
| Placebo | DRUG | Placebo will be orally administered to 4 subjects in each treatment period of each cohort. |
Inclusion Criteria: * Male between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitorin...
GSK2239633 is an investigational small molecule being developed for asthma. It is in Phase 1 clinical development and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both enrolling healthy male volunteers aged 18 years and older in the Netherlands.
GSK2239633 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting early-stage clinical research on this drug candidate for the treatment of asthma.
GSK2239633 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 30 participants. The drug is investigational and has not received regulatory approval for any use.
GSK2239633 has been studied in two completed Phase 1 trials. NCT01086462 was an intravenous microdose pharmacokinetic study with [14C]-GSK2239633, enrolling 6 healthy male volunteers. NCT01371812 was a first-time-in-human study, enrolling 24 healthy male volunteers. Both trials were conducted in the Netherlands.
GSK2239633 is the primary identifier for this investigational drug candidate. No alternative names have been disclosed in the available clinical trial information. The drug is being studied under this name in registered clinical trials for asthma.