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MDCO-157

Phase 1

Undisclosed | Small molecule | Other |Novartis AG|Trials Updated: Feb 22, 2018

MDCO-157 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

MDCO-157 clinical trials

MDCO-157 · 1 trial · 1 indication

Phase 1 1
NCT01860105Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an EvaluationPharmacokinetics and Pharmacodynamics in Healthy Volunteers
COMPLETED37 Analytics
PHASE1COMPLETED
Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation
Pharmacokinetics and Pharmacodynamics in Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Response of MDCO-157 (3 doses) compared to Plavix 300 mg
24 hr

To evaluate the dose-response of MDCO-157 (at 3 doses) compared to Plavix (300 mg), using Emax and AUEC with VASP, over 24 hours: * Maximum effect of P2Y12 receptor inhibition (Emax) using VASP (flow cytometry) * Area under the effect of P2Y12 receptor inhibition time curve (AUEC) using VASP (flow cytometry)

Secondary Endpoints

Pharmacokinetics (PK) of MDCO-157 and its metabolites
24 hrs
Safety and tolerability
48 hrs post each treatment period
Dose response of MDCO-157 as assessed by LTA
24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
75mg MDCO-157ACTIVE_COMPARATORiv
150mg MDCO-157ACTIVE_COMPARATORiv
300mg MDCO-157ACTIVE_COMPARATORiv
300mg PLAVIXACTIVE_COMPARATORoral

Interventions

NameTypeDescription
MDCO-157DRUGintravenous administration
PLAVIXDRUGoral administration
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Healthy males or females 18 to 45 years of age, inclusive. * Provide written informed consent for genetic testing and written informed consent for the study before initiation of any study related procedures * Affiliated to the French social security system * Screening and basel...

Countries:France
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Frequently asked questions about MDCO-157

What is MDCO-157?

MDCO-157 is an investigational small molecule drug developed by Novartis AG (ticker NVS). It has been studied in a Phase 1 clinical trial in healthy volunteers to evaluate its pharmacokinetics and pharmacodynamics. The specific therapeutic indication for MDCO-157 has not been disclosed.

Who is developing MDCO-157?

MDCO-157 is being developed by Novartis AG, which trades under the ticker symbol NVS. Novartis is a multinational pharmaceutical company. The drug is currently in Phase 1 clinical development.

What phase is MDCO-157 in?

MDCO-157 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials at this time. The completed trial enrolled 37 healthy volunteers.

What clinical trials is MDCO-157 in?

MDCO-157 has been evaluated in a single Phase 1 clinical trial, NCT01860105, titled "Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation." The trial was completed, enrolled 37 participants, and was conducted in France.

What does MDCO-157 target?

The molecular target of MDCO-157 has not been disclosed. It is a small molecule drug, but no specific target or mechanism of action information is available.