Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01469637
First received: November 4, 2011
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone & in combination with MMX Mesalazine/mesalamine.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: sulfamethoxazole + MMX placebo Drug: Sulfamethoxazole + 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 Sulfamethoxazole 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 Development LLC:
Primary Outcome Measures:
- Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole [ 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 of how much and how long a drug stays in a body.
- Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole [ 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: | 44 |
| Study Start Date: | November 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sulfamethoxazole + MMX placebo |
Drug: sulfamethoxazole + MMX placebo
800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4.
|
| Experimental: Sulfamethoxazole + MMX Mesalazine/mesalamine |
Drug: Sulfamethoxazole + MMX Mesalazine/mesalamine
800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4
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:
- 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.
Exclusion Criteria
- 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 sulfamethoxazole/trimethoprim, closely related compounds, or any of the stated ingredients
- A history of, or current, pancreatitis
Contacts and Locations More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT01469637 History of Changes |
| Other Study ID Numbers: | SPD476-117 |
| Study First Received: | November 4, 2011 |
| Results First Received: | September 26, 2012 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sulfamethoxazole Mesalamine Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 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 June 17, 2013