Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK189075A · 1 trial · 1 indication
Hematology, Clinical Chemistry, Urinalysis
12-lead ECG and continuous ECG monitoring.
urine output, and the number of micturations will be recorded.
Blood electrolyte concentrations (Na, K, Cl, Ca, Mg and bicarbonate)
creatinine clearance (24-hours \[h\])
Area under the plasma concentration-time curve \[AUC(0 last)\], Area under the plasma concentration-time curve \[AUC(0-infinity)\], Maximum observed plasma concentration (Cmax), Time to maximum observed plasma concentration (tmax), Plasma elimination half-life (t1/2), Area under the plasma concentration-time curve for the metabolite \[AUCm(0-last)\]/ Area under the plasma concentration-time curve for the parent \[AUCp(0-last)\], and AUCm(0-infinity)/AUCp(0-infinity) ratios.
Urine samples for creatinine, glucose, and electrolytes (Na, K, Cl) measurements will be obtained.
number of adverse events collected during study
Blood pressure and heart rate.
| Arm | Type | Description |
|---|---|---|
| Part A Treatment 1 | EXPERIMENTAL | GSK189075A 20mg |
| Part A Treatment 2 | EXPERIMENTAL | GSK189075A 50mg |
| Part A Treatment 3 | EXPERIMENTAL | GSK189075A 150mg |
| Part A Treatment 4 | EXPERIMENTAL | GSK189075A 500mg |
| Part A Treatment 5 | EXPERIMENTAL | GSK189075A 1000mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Part B Low dose | EXPERIMENTAL | low dose chosen from Part A |
| Part B High Dose | EXPERIMENTAL | high dose chosen from Part A |
| Name | Type | Description |
|---|---|---|
| GSK189075A | DRUG | 20mg, 50mg, 150mg, 500mg, 1000mg or Placebo |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Women must be of non-childbearing potential. Non-childbearing potential is defined as: Post-menopausal females defined as being amenorrhoeic for greater than one year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indica...
GSK189075A is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development, meaning it is still being studied in early-stage trials and is not yet approved for use.
GSK189075A is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for Type 2 Diabetes Mellitus.
GSK189075A is in Phase 1 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not been approved by regulatory authorities. The drug is still undergoing early-stage clinical testing to assess its safety and tolerability.
GSK189075A has one completed clinical trial, NCT01571661, which was a first-time-in-human study. This Phase 1 trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of GSK189075A in healthy subjects and in subjects with Type 2 Diabetes Mellitus.
GSK189075A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The drug has completed an early-stage clinical trial, but it has not yet received regulatory approval for any use.