Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine
A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Amoxicillin Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects
1 other identifier
interventional
62
1 country
1
Brief Summary
This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin administered alone \& in combination with MMX Mesalazine/mesalamine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Oct 2011
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedStudy Start
First participant enrolled
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2011
CompletedResults Posted
Study results publicly available
September 14, 2012
CompletedJune 9, 2021
May 1, 2021
1 month
September 26, 2011
August 16, 2012
May 24, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin
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) for Amoxicillin
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)
Amoxicillin + MMX placebo
EXPERIMENTALAmoxicillin + MMX mesalazine/mesalamine
EXPERIMENTALInterventions
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
Eligibility Criteria
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 amoxicillin, closely related compounds, or any of the stated ingredients
- A history of, or current, pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
PRA International
Lenexa, Kansas, United States
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: 24868146DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
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
September 26, 2011
First Posted
September 28, 2011
Study Start
October 7, 2011
Primary Completion
November 20, 2011
Study Completion
November 20, 2011
Last Updated
June 9, 2021
Results First Posted
September 14, 2012
Record last verified: 2021-05