Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2647544 · 1 trial · 1 indication
Safety and tolerability parameters will include recording of AEs
Safety and tolerability parameters will include laboratory (haematology, clinical chemistry, urinalysis) values at Screening, Day -1, Day 3 and Follow-up (7-14 days post-last dose)
Safety and tolerability parameter will include the electrocardiogram (ECG) readings at Screening, Day -1, Day 1, Day 2, Day 3 and Follow-up (7-14 days post-last dose)
Safety and tolerability parameter will include the Telemetry ECG readings from 30 minutes pre-dosing till 48 hours post-dosing
Vital signs measurement include systolic and diastolic blood pressure and pulse rate at Screening, Day -1, Day 1, Day 2, Day 3, Day 4 and Follow-up (7-14 days post-last dose)
C-SSRS will be measured at Screening, Day -1, Day 1 (conducted prior to discharge) and Follow-up (7-14 days post-last dose)
| Arm | Type | Description |
|---|---|---|
| GSK2647544 | EXPERIMENTAL | The starting dose of GSK2647544 is 0.5 mg. The escalating doses to be administered will be determined based on study results from previous dose (s). |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| GSK2647544 | DRUG | Capsules containing 0.5mg to 50mg of GSK2647544. |
| Placebo | DRUG | Matching placebo capsules. |
Inclusion Criteria: * Healthy males who are 18 to 55 years of age, inclusive * Healthy as determined by a responsible and experienced physician * aspartate aminotransferase (AST), Alanine transaminase (ALT), alkaline phosphatase and bilirubin \<= 1.5xUpper Limit of Normal (ULN) * Average of triplic...
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GSK2647544 is an investigational small molecule being developed for Alzheimer's Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved and is still being studied for safety and tolerability in humans.
GSK2647544 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
GSK2647544 is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 27 participants. The drug is investigational and has not received regulatory approval for any use.
GSK2647544 has one completed clinical trial, NCT01702467, titled 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of GSK2647544 in Healthy Volunteers.' This was a Phase 1, placebo-controlled study conducted in Australia with 27 healthy male participants.
GSK2647544 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety, tolerability, and pharmacokinetics in healthy volunteers, and further studies would be needed before any approval could be considered.
No alternative names for GSK2647544 have been reported. The drug is identified solely by its code name GSK2647544 in clinical trial registries and scientific literature.