Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tab carvedilol · 1 trial · 1 indication
The pharmacokinetic parameters will include area under the time concentration curve (AUC) for both the enriched and non-enriched R- and S-isomers of carvedilol
The pharmacokinetic parameters will include maximum drug concentration (Cmax) for both the enriched and non-enriched R- and S-isomers of carvedilol
| Arm | Type | Description |
|---|---|---|
| Treatment A (27.5 mg total maximum dose) | EXPERIMENTAL | Single oral dose of carvedilol (25 milligram \[mg\]) as a 1 x 25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol drug substance under fasted conditions. |
| Treatment B (27.5 mg total maximum dose) | EXPERIMENTAL | Single oral dose of carvedilol (25 mg) as a 1 x 25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol drug substance under fasted conditions. |
| Treatment C (33.75 mg total maximum dose) | EXPERIMENTAL | Single oral dose of carvedilol (31.25 mg) as a 1 x 25 mg immediate release tablet, a 1 x 6.25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol drug substance under fasted conditions. |
| Treatment D (27.5 mg total maximum dose) | EXPERIMENTAL | Single oral dose of carvedilol (25 mg) as a 1 x 25 mg x immediate release tablet and up to 2.5 mg of enriched carvedilol drug substance under fed conditions. |
| Name | Type | Description |
|---|---|---|
| Tab carvedilol 25 mg | DRUG | Carvedilol 25 mg immediate release tablet |
| Tab carvedilol 6.25 mg | DRUG | Carvedilol 6.25 mg immediate release tablet |
| Powder carvedilol up to 2.5 mg | DRUG | Carvedilol up to 2.5 mg isotopically enriched drug substance powder |
Inclusion criteria * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG monitoring. * Male or female between 18 and 55 years of age inclusive, at the time of signing the informed c...
Tab carvedilol is an investigational small molecule developed by GSK plc (ticker GSK) for metabolic and cardiovascular indications. It has been studied in a Phase 1 clinical trial in healthy volunteers. The drug is not approved and remains in clinical development.
Tab carvedilol is being evaluated for metabolic and cardiovascular indications. It has been tested in a Phase 1 trial in healthy volunteers, not in patients with these conditions. No efficacy or approval for any indication has been established.
Tab carvedilol is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 trial for this asset.
Tab carvedilol is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials. The drug is investigational and has not been approved for any indication.
Tab carvedilol has been studied in one completed Phase 1 trial, NCT01793870, titled "A Study in Healthy Volunteers to Evaluate the Application of Stable Isotope Approach to Reduce Number of Subjects Needed for PK Studies." The trial enrolled 17 healthy volunteers in the United Kingdom and was controlled and randomized.