Evaluating how Glipizide dissolves and is absorbed in the body

Open-Label, Randomized, Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers

This study is testing how well a new version of Glipizide dissolves and is absorbed in the body of healthy volunteers to help improve future medications.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Michigan (other)
• Drugs / interventions: radiation
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT05159427 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the in vivo dissolution and systemic absorption of modified release formulations of Glipizide in healthy volunteers. Participants will undergo a single dosing phase where gastrointestinal fluids, blood, urine, and feces will be collected to measure Glipizide concentrations. The study seeks to gather essential gastrointestinal physiology data that will aid in developing predictive in vitro models for drug dissolution. The findings will support the optimization of oral drug products to enhance their safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a BMI between 18.5 and 35.

Not a fit: Patients with significant clinical illnesses or those who cannot provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved drug formulations that enhance the effectiveness and safety of oral medications.

How similar studies have performed: While studies on drug dissolution exist, this specific approach of direct sampling in healthy volunteers is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female adults age 18 to 55 years with BMI ranging from 18.5 to 35 kg/m2 inclusive
2. Ability to independently provide an informed consent
3. Demonstrate the ability to swallow a multivitamin pill that mimics a SmartPill capsule
4. Negative serum pregnancy test (for women of child-bearing potential)

Exclusion Criteria:

1. Unable to independently provide an informed consent for themselves or mentally incapacitated.
2. Physical disability (including blindness or deafness) that requires special arrangements.
3. Significant clinical illness, including cardiovascular disease, neurological disease, organ failure, or malignancy in the opinion of the investigator
4. Any surgical procedure within 3 weeks prior to screening
5. History and/or presence of severe seasonal allergies or severe allergic diseases including drug allergies, food allergies and allergy against the SmartPill® device
6. History and/or presence of hypersensitivity to any of the study drugs or the products' excipients
7. History and/or presence of hypersensitivity to Sulfonamide derivatives
8. History and/or presence of hypersensitivity to Lidocaine
9. History and/or presence of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of XIFAXAN
10. History and/or presence of hypersensitivity to acrylate or methacrylate, commonly used components of medical adhesives
11. Any other factor, condition, or disease, including, but not limited to, cardiovascular, respiratory, hematological, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the patient, alter drug absorption and pharmacokinetics or impact the validity of the study results.
12. Subjects with Type 1 Diabetes Mellitus (DM), diabetic ketoacidosis, with or without coma
13. Subjects with Glucose 6-phosphate dehydrogenase (G6PD) deficiency
14. History and/or presence of drug addiction or alcohol abuse within the past 12 months.
15. History of significant psychiatric or neurological illness, including seizure disorders.
16. Any medical or surgical conditions which might significantly interfere with the functions of gastrointestinal tract (e.g., gastric/intestinal bypass surgeries, fistulas, strictures, stenosis, or physiological/mechanical obstruction of the G.I tract, gastric bezoars, irritable bowel disease, crohn's disease, diverticulosis, or chronic narcotic use).
17. History of dysphagia to liquids, food, or pills
18. History of abdominal radiation therapy
19. Pregnant or lactating females
20. Any clinically significant abnormal lab values during screening in the opinion of the investigator.
21. Use of alcohol and/or nicotine containing products 48 hours prior to dosing visits, and throughout PK sampling visits.
22. Use of any medications and/or supplements, prescriptions or over the counter 1 week prior to beginning the study, and throughout the study except for birth control with approved methods of contraception when used consistently and correctly (Implants (i.e. Implanon, Nexplanon), Injectables (i.e. Depo-Provera), Combined, Oral Contraceptives, Intrauterine Devices (IUD's) (i.e. Mirena, ParaGard), and Sexual Abstinence are accepted).
23. Use of aspirin or any blood thinner medications.
24. Use of an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump.
25. Volunteers unwilling or unable to take the proposed drugs or undergo G.I intubation
26. Enrollment in a clinical trial in the past 30 days
27. Current enrollment in a clinical trial with another study drug, vaccine or medical device
28. Fasting blood glucose level \< 80 mg/dL.
29. Inability or unwillingness to fast for 19 hours.
30. Blood donations in the past 8 weeks except for apheresis.
31. Volunteer shows a positive result of COVID-19 Antigen Rapid test in dosing visits
32. Volunteer is having any of the following symptoms:

    * Fever (over 100.4 oF or 38 oC) or feeling feverish
    * New cough
    * New shortness of breath
33. Volunteer is having two of any of these symptoms:

    * Chills
    * Muscle aches
    * New URI symptom(s) (runny nose, nasal congestion, and/or sore throat)
    * New loss of sense of smell or sense of taste
    * New headache
34. Volunteer has been in close contact in the last 14 days with someone recently diagnosed with COVID-19
35. Volunteer has returned from international travel within the past 10 days

Where this trial is running

Ann Arbor, Michigan

• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)

Study contacts

• Study coordinator: Cathrin Ring

Conditions: Human Gastrointestinal Physiology Data, Clinical study, Glipizide, Modified release, Pharmacokinetics, In vivo dissolution, Local gastrointestinal concentration