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retapamulin

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

retapamulin · 1 trial · 1 indication

Phase 2 1
NCT00539994Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus AureusInfections, Bacterial
COMPLETED57 Analytics
PHASE2COMPLETED
Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
Infections, BacterialUnlock trial analytics

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 to 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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Frequently asked questions about retapamulin

What is Retapamulin, 1% used for?

Retapamulin, 1% is a small molecule antibiotic used for bacterial skin infections and other bacterial infections. It is being developed by GSK plc (ticker: GSK) and is currently in Phase 3 clinical development for these indications.

What does Retapamulin, 1% target?

Retapamulin, 1% is an antibiotic that works by inhibiting bacterial protein synthesis. It is being studied for the treatment of bacterial skin infections and other bacterial infections, including those caused by Staphylococcus aureus.

Who makes Retapamulin, 1%?

Retapamulin, 1% is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 3 clinical trials for bacterial skin infections.

What phase is Retapamulin, 1% in?

Retapamulin, 1% is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy for bacterial skin infections.

What clinical trials is Retapamulin, 1% in?

Retapamulin, 1% has been studied in clinical trials including NCT00539994, a Phase 2 study in healthy adults nasally colonized with Staphylococcus aureus, and NCT00684177, a Phase 3 study in patients with secondarily-infected traumatic lesions. Both trials have been completed.

Is Retapamulin, 1% the same as Altabax?

Retapamulin, 1% is also known by the brand name Altabax. It is an antibiotic ointment used to treat bacterial skin infections. The drug is being developed by GSK plc and is currently in Phase 3 clinical trials.