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CMX157

Phase 1

Undisclosed | Small molecule | Other |Jazz Pharmaceuticals plc|Trials Updated: Jul 4, 2011

CMX157 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2010

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

CMX157 clinical trials

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
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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?

CMX157 is an investigational small molecule drug being developed by Jazz Pharmaceuticals plc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. Its specific therapeutic indications have not been disclosed.

Who is developing CMX157?

CMX157 is being developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker JAZZ. The company sponsored the Phase 1 study of CMX157 conducted in the United States.

What phase is CMX157 in?

CMX157 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is CMX157 in?

CMX157 has been evaluated in one completed Phase 1 trial, NCT01080820, titled A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy Volunteers. The trial enrolled 36 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.

What was the design of the CMX157 Phase 1 trial?

The Phase 1 trial of CMX157, NCT01080820, was a randomized, double-blind, placebo-controlled study of a single dose in healthy volunteers. It enrolled 36 participants aged 18 years and older of all sexes in the United States and has been completed.