Correlation of Mesalamine Pharmacokinetics With Local Availability

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to provide data to the FDA correlating pharmacokinetics with local availability of medications within the gastrointestinal tract. This study will support the establishment of scientifically based standards for evaluating drugs which act locally within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve the physiologically based models for drug absorption from the intestine. Information from this study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of mesalamine products.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Michigan
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Mesalamine

Criteria

Inclusion Criteria

1. Adults age 18 to 55.

2. Male or female voluntarily able to give informed consent.

3. Body mass index (BMI) 18.5 to 35.

Exclusion Criteria

1. Adults unable to consent for themselves or mentally incapacitated.

2. Prisoners.

3. Significant clinical illness within 3 weeks prior to Screening.

4. Use of concomitant medications within 2 weeks prior to receiving study drug, including but not limited to prescription drugs, herbal and dietary supplements, over the counter medications, and vitamins. Oral contraception is permitted.

5. History of gastrointestinal surgery.

6. History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the ingredients of Asacol, Pentasa, Apriso, or Lialda.

7. History of severe allergic diseases including drug allergies, with the exception of seasonal allergies.

8. Any other factor, condition, or disease, including, but not limited to, cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the patient or impact the validity of the study results.

9. History of drug addiction or alcohol abuse within the past 12 months.

10. Pregnant or lactating females.

11. Surgery within the past 3 months.

12. Received an investigational drug within 60 days prior to receiving the study drug.

13. Any clinically significant abnormal lab values during Screening.