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Moxidectin

Phase 2

Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: Feb 15, 2011

Moxidectin development status

Highest phase Phase 2 (NCT01035619)
Phase scored for PFEPhase 1
Registered trials 4 across 2 sponsors since Aug 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment66

FDA Designations

No designations recorded

Moxidectin clinical trials

Moxidectin · 2 trials · 1 indication

Phase 1 2
NCT00736697Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of MoxidectinInfection
COMPLETED54 Analytics
NCT00751764Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding WomenInfection
COMPLETED12 Analytics
PHASE1COMPLETED
Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin
InfectionUnlock trial analytics
PHASE1COMPLETED
Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women
InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Blood samples
4 months

Secondary Endpoints

Electrocardiograms
4 months
Safety based on adverse event monitoring, vital sign measurements, 12-lead ECGs and routine lab tests.
4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
moxidectinDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Men or women of non childbearing potential aged 18 to 50 years inclusive at screening. * Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. Exclusion criteria * Any clinical important deviation from normal limits in physic...

Countries:FranceUnited Kingdom
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Frequently asked questions about Moxidectin

What is moxidectin used for?

Moxidectin is being studied for the treatment of infection as an infectious disease therapy. It is a small molecule drug in Phase 1 clinical development. The completed trials enrolled healthy volunteers rather than patients with active infection, so its use in treating infection remains investigational.

Who makes moxidectin?

Pfizer, Inc. is the developer of moxidectin, and the company trades under the ticker PFE. Pfizer sponsored the Phase 1 trials evaluating the drug's excretion into breast milk and the effect of a high-fat meal on its bioavailability and pharmacokinetics.

What phase is moxidectin in?

Moxidectin is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved for the infection indication described in this development program.

What clinical trials is moxidectin in?

Moxidectin has been studied in two completed Phase 1 trials. NCT00751764 evaluated excretion of moxidectin into breast milk in lactating, non-breastfeeding women in the United Kingdom. NCT00736697 evaluated the effect of a high-fat meal on bioavailability and pharmacokinetics of a single dose in France.

How many patients were enrolled in moxidectin trials?

The two completed Phase 1 trials of moxidectin enrolled a total of 66 participants. NCT00751764 enrolled 12 lactating, non-breastfeeding women aged 21 years and older, and NCT00736697 enrolled 54 participants aged 18 years and older. Both studies used healthy volunteers.

Were the moxidectin trials randomized or blinded?

The moxidectin Phase 1 trials were randomized but not double-blind, and they used an uncontrolled design. NCT00751764 enrolled only female participants in the United Kingdom, while NCT00736697 enrolled participants of any sex in France. Neither trial selected participants based on a biomarker.