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MMX Mesalazine/mesalamine+ Ciprofloxacin

Phase 1

Healthy | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 9, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

MMX Mesalazine/mesalamine+ Ciprofloxacin · 1 trial · 1 indication

Phase 1 1
NCT01402947Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/MesalamineHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR
Assessed over a 24-hour period starting post-dose on day 4

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR
Assessed over a 24-hour period starting post-dose on day 4

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ciprofloxacin + MMX placeboEXPERIMENTAL -
MMX Mesalazine/mesalamine + CiprofloxacinEXPERIMENTAL -

Interventions

NameTypeDescription
Ciprofloxacin XR + MMX PlaceboDRUGMMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
MMX Mesalazine/mesalamine + Ciprofloxacin XRDRUGMMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria 1. Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. 2. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: * Male, or * Non-pregnant, ...

Countries:United States
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Frequently asked questions about MMX Mesalazine/mesalamine+ Ciprofloxacin

What is MMX Mesalazine/mesalamine + Ciprofloxacin used for?

MMX Mesalazine/mesalamine + Ciprofloxacin is a combination of two small molecules being studied in healthy volunteers. It is currently in Phase 1 clinical development, with the completed trial NCT01402947 evaluating the drug interaction between Ciprofloxacin XR and MMX Mesalazine/Mesalamine. The study enrolled 30 participants in the United States.

Who makes MMX Mesalazine/mesalamine + Ciprofloxacin?

Takeda Pharmaceutical Company Limited (ticker: TAK) is developing MMX Mesalazine/mesalamine + Ciprofloxacin. The drug is a small molecule combination therapy currently in Phase 1 clinical trials. Takeda conducted a completed Phase 1 study (NCT01402947) in healthy volunteers to assess the drug interaction between the two components.

What phase is MMX Mesalazine/mesalamine + Ciprofloxacin in?

MMX Mesalazine/mesalamine + Ciprofloxacin is in Phase 1 clinical development. The drug has one completed Phase 1 trial (NCT01402947) with 30 enrolled participants. It is investigational and not yet approved for any indication. The study was conducted in healthy volunteers in the United States.

What clinical trials is MMX Mesalazine/mesalamine + Ciprofloxacin in?

MMX Mesalazine/mesalamine + Ciprofloxacin has one completed clinical trial, NCT01402947, titled 'Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine.' This Phase 1 study enrolled 30 healthy volunteers in the United States, with participants aged 18 years and older. The trial was controlled and randomized but not double-blind.

Is MMX Mesalazine/mesalamine + Ciprofloxacin the same as mesalamine or ciprofloxacin alone?

MMX Mesalazine/mesalamine + Ciprofloxacin is a combination of two drugs: mesalazine (also known as mesalamine) and ciprofloxacin. It is not the same as either drug alone, as it combines both active ingredients in a single product. The Phase 1 trial studied the drug interaction between Ciprofloxacin XR and MMX Mesalazine/Mesalamine.