Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2230672 · 1 trial · 1 indication
Systolic and diastolic blood pressure will be measured on Day -1, post dose 2 hours (hrs), 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Heart rate will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Body temperature will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Fecal occult blood testing will be conducted on Screening (2 samples during Screening period) and each dosing period (anytime from dosing to next dose).
Electrocardiogram will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
| Arm | Type | Description |
|---|---|---|
| Sequence 1: GSK2230672 10mg, 30mg, 90mg, and Placebo | EXPERIMENTAL | Subjects will receive GSK2230672 10 mg in period 1, GSK2230672 30 mg in Period 2, GSK2230672 90 mg in Period 3 and placebo in period 4. |
| Sequence 2:GSK2230672 10mg, 30mg, Placebo, and GSK2230672 90mg | EXPERIMENTAL | Subjects will receive GSK2230672 10 mg in period 1, GSK2230672 30 mg in Period 2, placebo in period 3, and GSK2230672 90 mg in period 4. |
| Sequence 3:GSK2230672 10mg, Placebo, GSK2230672 90mg and 180mg | EXPERIMENTAL | Subjects will receive GSK2230672 10 mg in period 1, placebo in Period 2, GSK2230672 90 mg in Period 3 and GSK2230672 180 mg in period 4. |
| Sequence 4: Placebo, GSK2230672 30mg, 90mg and 180mg | EXPERIMENTAL | Subjects will receive placebo in period 1, GSK2230672 30 mg in Period 2, GSK2230672 90 mg in Period 3 and GSK2230672 180 mg in period 4. |
| Name | Type | Description |
|---|---|---|
| GSK2230672 | DRUG | It will be supplied as white to slightly colored, round, film coated tablet for oral administration containing 10 mg or 45 mg of GSK2330672. |
| Placebo | DRUG | It will be supplied as placebo tablets (with no GSK2230672) visually matching to GSK2230672 |
Inclusion Criteria: * Japanese male aged between 20 and 64 years of age inclusive, at the time of signing the informed consent * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests ...
GSK2230672 is an investigational small molecule being developed for cholestasis, a condition in which bile flow from the liver is impaired. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its potential to treat this gastrointestinal condition.
GSK2230672 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with cholestasis.
GSK2230672 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The drug is being studied in early-stage clinical trials to assess its safety, tolerability, and pharmacokinetics in humans.
GSK2230672 has one completed clinical trial, identified as NCT02801981, titled 'Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers.' This Phase 1 study enrolled 16 healthy male participants in Japan and was designed to evaluate the drug's safety and tolerability at escalating doses.
Yes, GSK2230672 and GSK2330672 refer to the same investigational drug. The clinical trial record for this compound uses the name GSK2330672, while the drug is also referred to as GSK2230672. Both names identify the same small molecule being developed for cholestasis.