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SB-656933

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Aug 8, 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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00615576Repeat Dose Study in Male Healthy Volunteer SmokersPHASE1 COMPLETED 13 — — Mar 26, 2008Jul 24, 2008Aug 8, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
-what the body does to the drug over a 17 day of dosing with 100mg of SB656933. -Safety of SB-656933: Adverse events, blood pressure, heart rate, electrocardiogram, epididymal ultrasound and lab tests
17 days
-what the body does to the drug over a 17 day of dosing with 100mg of SB656933 by taking PK samples at:
pre-dose and at 0.5,1,2,3,4,6,8,12 and 24 hours post-dose on days 1 and 14; pre-dose on Day7. Additional samples at 32, 48 and 72 hours post-dose wil
-Safety of SB-656933: Adverse events every day for entire study period: blood pressure , heart rate and temperature
taken pre-dose, 30min, 1hr, and 2hr on Day1, Day2, Day7 and Day14 (supine only);
electrocardiogram
pre-dose, 2hr and 4 hr on Day1
Secondary Endpoints
- Looking at the actual sample size data to determine a larger theoretical population. -What the drug does to the body when present at its lowest level on day 14 as compared before drug given.
17 days
Safety and tolerability of SB-656933 in subjects with cystic fibrosis, including adverse events, vital signs, clinical laboratory assessments, electrocardiographic (ECG) parameters, and lung function (FVC, FEV1)
Up to Day 28
Fluorocytometric quantitation of CXCL1-induced CD11b expression on peripheral blood neutrophils in ex-vivo assay.
Up to Day 14
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Study Design & Arms
AllocationRANDOMIZED
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Subjects receiving SB-656933EXPERIMENTALEligible subjects will be randomized to receive once daily doses of 100 milligrams of SB- 656933 for 14 days.
Subjects receiving placeboPLACEBO_COMPARATOREligible subjects will be randomized to receive placebo for 14 days.
Interventions
NameTypeDescription
SB-656933DRUGSB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily.
PlaceboDRUGA placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult male smokers who are between 18-65 years of age with normal genitourinary anatomy based on physical examination. * The subjects should have a normal colour Doppler epididymal ultrasound (normal blood flow and epididymal morphology) at screening. * The first 10 mL...

Countries:United Kingdom
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