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Tab carvedilol

Phase 1

Metabolic, Cardiovascular | Small molecule | Metabolic |GSK plc|Last Updated: Jun 12, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01793870A Study in Healthy Volunteers to Evaluate the Application of Stable Isotope Approach to Reduce Number of Subjects Needed for PK StudiesPHASE1 COMPLETED 17 — — Jan 15, 2013Jun 17, 2013Jun 12, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
The AUC for both the enriched and non-enriched R- and S-isomers of carvedilol
Day 1:pre-dose, 15 minutes (mins), 30 mins, 45 mins, 1 hour (h), 2 h, 3 h, 4 h, 6 h, 8 h and 12 h post-dose; Day 2: at 24 h and 36 h post dose

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 Cmax for both the enriched and non-enriched R- and S-isomers of carvedilol
Day 1:pre-dose, 15 minutes (mins), 30 mins, 45 mins, 1 hour (h), 2 h, 3 h, 4 h, 6 h, 8 h and 12 h post-dose; Day 2: at 24 h and 36 h post dose

The pharmacokinetic parameters will include maximum drug concentration (Cmax) for both the enriched and non-enriched R- and S-isomers of carvedilol

Secondary Endpoints
The Tmax for both the enriched and non-enriched R- and S-isomers of carvedilol (as data permit)
Day 1:pre-dose, 15 minutes (mins), 30 mins, 45 mins, 1 hour (h), 2 h, 3 h, 4 h, 6 h, 8 h and 12 h post-dose; Day 2: at 24 h and 36 h post dose
The T1/2 for both the enriched and non-enriched R- and S-isomers of carvedilol (as data permit)
Day 1:pre-dose, 15 minutes (mins), 30 mins, 45 mins, 1 hour (h), 2 h, 3 h, 4 h, 6 h, 8 h and 12 h post-dose; Day 2: at 24 h and 36 h post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment A (27.5 mg total maximum dose)EXPERIMENTALSingle 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)EXPERIMENTALSingle 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)EXPERIMENTALSingle 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)EXPERIMENTALSingle 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.
Interventions
NameTypeDescription
Tab carvedilol 25 mgDRUGCarvedilol 25 mg immediate release tablet
Tab carvedilol 6.25 mgDRUGCarvedilol 6.25 mg immediate release tablet
Powder carvedilol up to 2.5 mgDRUGCarvedilol up to 2.5 mg isotopically enriched drug substance powder
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United Kingdom
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