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 being studied for metabolic and cardiovascular conditions. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being evaluated in healthy volunteers to understand its pharmacokinetic properties.
Tab carvedilol 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 small molecule for metabolic and cardiovascular indications.
Tab carvedilol is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is being studied for its safety and pharmacokinetic profile in healthy volunteers.
Tab carvedilol has one completed Phase 1 clinical trial registered under NCT01793870. The study, titled "A Study in Healthy Volunteers to Evaluate the Application of Stable Isotope Approach to Reduce Number of Subjects Needed for PK Studies," enrolled 17 participants in the United Kingdom. The trial was controlled but not double-blinded.
Tab carvedilol is a formulation of carvedilol, a small molecule being investigated for metabolic and cardiovascular conditions. The drug is in Phase 1 development by GSK plc. No alternative names for this specific formulation have been disclosed.