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SK&F-105517-D

Phase 1

Heart Failure, Congestive | Small molecule | Cardiovascular |GSK plc|Last Updated: Aug 2, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00742508A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart FailurePHASE1 COMPLETED 41 — — Aug 28, 2008Aug 21, 2009Aug 2, 201723 Japan
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)
Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D

Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.

Mean Change From Baseline in Albumin and Total Protein at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value

Mean Change From Baseline in Amylase at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value

Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value

Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value

Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.

Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Hematocrit at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Red Blood Cell Count at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Mean Corpuscular Volume at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8
Baseline and Week 8

Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.

Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Heart Rate at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Mean Change From Baseline in Weight at Week 8
Baseline and Week 8

Mean change from baseline was calculated as the Week 8 value minus the Baseline value.

Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8
Baseline and Week 8

There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.

Cardiothoracic Ratio at Baseline and Week 8
Baseline and Week 8

Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.

Secondary Endpoints
Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Week 8
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Week 8
Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SK&F-105517-D groupEXPERIMENTALSK\&F-105517-D 10-80 mg/day
Carvedilol-IR groupOTHERCarvedilol-IR 5-20 mg/day
Interventions
NameTypeDescription
SK&F-105517-D 10 mg capsuleDRUG1 capsule once a day
Carvedilol-immediate release (IR) 2.5 mg tabletDRUG1 or 2 tablet(s) twice a day
SK&F-105517-D 20 mg capsuleDRUG1 capsule once a day
SK&F-105517-D 40 mg capsuleDRUG1 or 2 capsule(s) once a day
Carvedilol-IR 10 mg tabletDRUG1 tablet twice a day
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Eligibility Criteria
Age Range20 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion criteria: * Patients with symptomatically stable chronic heart failure (CHF) based on ischemic heart disease or dilated cardiomyopathy * Patients who are maintained on basic heart failure therapy with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) ...

Countries:Japan
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