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CMX157

Phase 1

Healthy | Small molecule | Other |Jazz Pharmaceuticals plc|Last Updated: Jul 4, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

CMX157 · 1 trial · 1 indication

Phase 1 1
NCT01080820A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy VolunteersHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy Volunteers
Healthy
NCT0108082036
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Study Endpoints

Primary Endpoints

Adverse events (AEs), absolute values and changes over time of clinical chemistry including troponin, hematology, and urinalysis, vital signs (blood pressure (BP) and heart rate), electrocardiogram
dosing-28 days post-dose

Secondary Endpoints

CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration.
dosin - 28 days post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Placebo + VireadPLACEBO_COMPARATOR -
VireadACTIVE_COMPARATOR -
CMX157 + VireadEXPERIMENTAL -

Interventions

NameTypeDescription
CMX157DRUGOne single oral dose of CMX157 will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the CMX157 dose.
PlaceboDRUGOne single oral dose of placebo will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the placebo dose.
VireadDRUGOne single oral dose of 300mg Viread.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1\. Males or females of non-childbearing potential, 18 to 55 years of age. Males must be able and willing to use adequate contraceptive methods throughout the study. Exclusion Criteria: 1. Currently nursing females, pregnant females, or females of child-bearing potential. 2. H...

Countries:United States
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Frequently asked questions about CMX157

What is CMX157 used for?

CMX157 is an investigational small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics after a single dose. CMX157 is not approved by the FDA and remains in clinical investigation.

Who makes CMX157?

CMX157 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.

What phase is CMX157 in?

CMX157 is in Phase 1 clinical development. A Phase 1 trial has been completed, and there are no active trials currently listed. The drug is investigational and has not been approved by the FDA, as it is still in the early stages of clinical testing.

What clinical trials is CMX157 in?

CMX157 has one completed Phase 1 clinical trial, identified as NCT01080820. This study was a randomized, double-blind, placebo-controlled trial that evaluated the safety, tolerability, and pharmacokinetics of a single dose of CMX157 in 36 healthy volunteers in the United States.

Is CMX157 FDA approved?

No, CMX157 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug has not yet received regulatory approval and is still being studied for its safety and tolerability in healthy volunteers.