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RPX7009 and RPX2014

Phase 1

Healthy Subjects | Small molecule | Other |Novartis AG|Last Updated: Mar 5, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

RPX7009 and RPX2014 · 2 trials · 3 indications

Phase 1 2
NCT02073812Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult SubjectsHealthy Subjects
COMPLETED26 Analytics
NCT02020434The Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal InsufficiencySubjects With Varying Degrees of Renal Insufficiency and
COMPLETED32 Analytics
PHASE1COMPLETED
Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects
Healthy Subjects
NCT0207381226
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PHASE1COMPLETED
The Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal Insufficiency
Subjects With Varying Degrees of Renal Insufficiency and
NCT0202043432
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Study Endpoints

Primary Endpoints

Pharmacokinetics from baseline through the end of the study
2 days

Assessment of plasma, ELF and AM concentrations of RPX2014 and RPX7009 after 3 doses of Carbavance

Safety from baseline through the end of the study
7days

Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis

Secondary Endpoints

IV Carbavance concentrations in lung fluid
2 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Multiple dose of Carbavance (RPX7009/RPX2014)EXPERIMENTALMultiple dose of Carbavance
Single dose of RPX7009 and RPX2014EXPERIMENTALSingle dose of combination RPX7009 and RPX2014

Interventions

NameTypeDescription
RPX7009 and RPX2014DRUGThe study is designed to enroll approximately 25 healthy subjects. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Carbavance (RPX7009/RPX2014)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening. 2. Body mass index (BMI) ≥ 18.5 and ≤ 30 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at the time of screening. 3. Medically healthy with clinically insignificant scree...

Countries:United States
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