Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01418365
First received: August 15, 2011
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone & in combination with MMX® Mesalazine/mesalamine


Condition Intervention Phase
Healthy
Drug: Metronidazole + MMX Mesalazine/mesalamine placebo
Drug: Metronidazole + MMX Mesalazine/mesalamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Metronidazole Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ] [ Designated as safety issue: No ]
    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) at Steady State for Metronidazole [ Time Frame: Assessed over a 24-hour period starting post-dose on day 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole + MMX placebo Drug: Metronidazole + MMX Mesalazine/mesalamine placebo
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally
Experimental: Metronidazole + MMX Mesalazine/mesalamine Drug: Metronidazole + MMX Mesalazine/mesalamine
Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
Other Name: Lialda

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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 metronidazole, closely related compounds, or any of the stated ingredients
  7. A history of, or current, pancreatitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418365

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

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01418365     History of Changes
Other Study ID Numbers: SPD476-116
Study First Received: August 15, 2011
Results First Received: July 16, 2012
Last Updated: August 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metronidazole
Mesalamine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014