Overview

This trial is active, not recruiting.

Condition local drug concentration in gastrointestinal tract
Treatments pentasa 500 mg capsule x 2 with 240 ml water; single dose, apriso 375 mg capsule x 3 with 240 ml water; single dose, lialda 1200 mg tablet x 1 with 240 ml water; single dose, asacol 400 mg tablet x 1 with 240 ml water; single dose
Sponsor University of Michigan
Collaborator Food and Drug Administration (FDA)
Start date April 2012
End date September 2015
Trial size 30 participants
Trial identifier NCT01999400, FDA-SOL-1120920, HHSF223201000082C, HHSF223201300460A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Pentasa 500 mg capsule x 2 with 240 mL water, single dose
pentasa 500 mg capsule x 2 with 240 ml water; single dose
(Experimental)
Apriso 375 mg capsule x 3 with 240 mL water, single dose
apriso 375 mg capsule x 3 with 240 ml water; single dose
(Experimental)
Lialda 1200 mg tablet x 1 with 240 mL water, single dose
lialda 1200 mg tablet x 1 with 240 ml water; single dose
(Experimental)
Asacol 400 mg tablet x 1 with 240 mL water, single dose
asacol 400 mg tablet x 1 with 240 ml water; single dose

Primary Outcomes

Measure
concentration of mesalamine and metabolite (N-acetyl-mesalamine) in plasma
time frame: see Description
concentration of mesalamine and metabolite (N-acetyl-mesalamine) in urine
time frame: see Description
concentration of mesalamine and metabolite (N-acetyl-mesalamine) in feces
time frame: see Description
concentration of mesalamine and metabolite (N-acetyl-mesalamine) in gastrointestinal fluid
time frame: see Description
pH of gastrointestinal fluid
time frame: see Description

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Correlation of Mesalamine Pharmacokinetics With Local Availability
Principal investigator Duxin Sun, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Michigan.