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retapamulin

Phase 2

Infections, Bacterial | Small molecule | Infectious Disease |GSK plc|Last Updated: Dec 15, 2016

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00539994Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus AureusPHASE2 COMPLETED 57Sep 1, 2007Jan 1, 2008Dec 15, 20164 United States
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Study Endpoints
Primary Endpoints
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing
Days 1 and 3

Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing
Day 5

Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing
Days 1 and 3

Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.

Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing
Day 5

Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL

Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus
Day 12

Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.

Secondary Endpoints
Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3
Days 1 and 3
Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5
Day 5
Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus
Days 7 and 33
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment BEXPERIMENTAL200mg BID retapamulin 5 days
Treatment CPLACEBO_COMPARATOR200mg BID placebo 5 days
Treatment AEXPERIMENTAL200mg BID retapamulin 3 days and placebo BID 2 days for a total of 5 days
Interventions
NameTypeDescription
retapamulinDRUG200mg BID retapamulin 3 days
PlaceboDRUG200mg BID placebo 5 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Male and female subjects between the ages of 18 and 65, inclusive. A female is eligible to enter and participate in this study if she is non-pregnant, nonlactating and if she is of: * non-childbearing potential (i.e., physiologically incapable of becoming pregnant), includi...

Countries:United States
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