Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

NCT01418365 | Completed Phase 1 Results

• 1 other identifier: SPD476-116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole

  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.

  Assessed over a 24-hour period starting post-dose on day 4

• Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole

  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.

  Assessed over a 24-hour period starting post-dose on day 4

Study Arms (2)

Metronidazole + MMX placebo

EXPERIMENTAL

Drug: Metronidazole + MMX Mesalazine/mesalamine placebo

Metronidazole + MMX Mesalazine/mesalamine

EXPERIMENTAL

Drug: Metronidazole + MMX Mesalazine/mesalamine

Interventions

Metronidazole + MMX Mesalazine/mesalamine placebo DRUG

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

Metronidazole + MMX placebo

Metronidazole + MMX Mesalazine/mesalamine DRUG

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

Also known as: Lialda

Metronidazole + MMX Mesalazine/mesalamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
• 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.
• A history of or current clinically relevant moderate or severe renal or hepatic impairment.
• A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
• Known or suspected intolerance or hypersensitivity to the investigational product or metronidazole, closely related compounds, or any of the stated ingredients
• A history of, or current, pancreatitis.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

PRA International

Lenexa, Kansas, United States

Location

Related Publications (1)

• Pierce D, Corcoran M, Martin P, Barrett K, Inglis S, Preston P, Thompson TN, Willsie SK. Effect of MMX(R) mesalamine coadministration on the pharmacokinetics of amoxicillin, ciprofloxacin XR, metronidazole, and sulfamethoxazole: results from four randomized clinical trials. Drug Des Devel Ther. 2014 May 14;8:529-43. doi: 10.2147/DDDT.S55373. eCollection 2014.

  PMID: 24868146 DERIVED

MeSH Terms

Interventions

Metronidazole; Mesalamine

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: August 22, 2011
• Primary Completion: October 5, 2011
• Study Completion: October 5, 2011
• Last Updated: June 9, 2021
• Results First Posted: August 17, 2012

Record last verified: 2021-05

Locations

US (1)