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SB756050

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Jul 13, 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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00733577A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.PHASE1 COMPLETED 48 — — Aug 11, 2008Mar 3, 2009Jul 13, 20174 United States
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Study Endpoints
Primary Endpoints
Safety measures including: AEs daily; laboratory testing: day -1,2,5,7 and follow up; ECG: day -1, 2, 5, 6, 7 and follow-up; vital signs: daily; PK parameters day -1,5, and 6.
6 days of dosing
Secondary Endpoints
Pharmacodynamic endpoints will include fasting and meal or OGTT-related weighted mean AUC for glucose, GLP-1 (total and active), glucagon, insulin, PYY (active) and C-peptide levels.
6 days of dosing
Safety and tolerability parameters including adverse events, clinical laboratory, ECGs and vital signs assessments.
6 days of dosing
Subject reports of hunger and craving as reported on the Hunger and Craving questionnaire
6 days of dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL15 mg SB756050 or placebo
Cohort 2EXPERIMENTALPlanned dose for Cohorts 2 50mg SB756050 or placebo
Cohort 3EXPERIMENTALPlanned dose for Cohort 3 150mg SB756050 or placebo
Cohort 4EXPERIMENTALPlanned dose for Cohort 4 600mg SB756050 or placebo
Interventions
NameTypeDescription
SB756050DRUGdoses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent * A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or p...

Countries:United States
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