Sulfamethoxazole Drug Interaction Study With MMX� Mesalazine/Mesalamine

Condition(s) targeted: Healthy

Intervention: sulfamethoxazole + MMX placebo (Drug); Sulfamethoxazole + MMX Mesalazine/mesalamine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Patrick Martin, Study Director, Affiliation: Shire

This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone & in combination with MMX Mesalazine/mesalamine.

Official title: A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Sulfamethoxazole Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole

Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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 sulfamethoxazole/trimethoprim, closely related compounds, or any of the stated ingredients 7. A history of, or current, pancreatitis

PRA Inrernational, Lenexa, Kansas 66219, United States

Starting date: November 2011
Last updated: September 26, 2012