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Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine

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ClinicalTrials.gov Identifier: NCT01402947
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : July 6, 2012
Last Update Posted : July 6, 2012
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone & in combination with MMX Mesalazine/mesalamine.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ciprofloxacin XR + MMX Placebo Drug: MMX Mesalazine/mesalamine + Ciprofloxacin XR Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Ciprofloxacin XR Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects
Study Start Date : July 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ciprofloxacin + MMX placebo Drug: Ciprofloxacin XR + MMX Placebo
MMX 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
Experimental: MMX Mesalazine/mesalamine + Ciprofloxacin Drug: MMX Mesalazine/mesalamine + Ciprofloxacin XR
MMX 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
Other Name: Lialda



Primary Outcome Measures :
  1. Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR [ Time Frame: 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.

  2. Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR [ Time Frame: 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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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, non-lactating female
    • Females must be at least 90 days post-partum or nulliparous.

Exclusion Criteria

  1. A history of current or recurrent disease that could affect the colon. This includes gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel Syndrome. Subjects who have a history of chronic constipation, which is physician diagnosed and treated, will also be excluded from the study (frequency of bowel movements >48 hours between samples).
  2. A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
  3. A history of gastrointestinal surgery performed within the past 12 months prior to the first dose of investigational product, with the exception of an appendectomy.
  4. A history of or current clinically relevant moderate or severe renal or hepatic impairment.
  5. A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
  6. Known or suspected intolerance or hypersensitivity to the investigational product or ciprofloxacin XR, closely related compounds, or any of the stated ingredients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402947


Locations
United States, Kansas
PRA International
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Shire
Investigators
Study Director: Patrick Martin Shire

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01402947     History of Changes
Other Study ID Numbers: SPD476-115
First Posted: July 26, 2011    Key Record Dates
Results First Posted: July 6, 2012
Last Update Posted: July 6, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Ciprofloxacin
Mesalamine
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents