RECRUITING

Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study is to evaluate the in vivo drug dissolution and systemic absorption of modified release formulations of the BCS Class II drug Glipizide by direct sampling of stomach and small intestinal luminal content, blood, urine and feces. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

Official Title

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

Quick Facts

Study Start:2022-03-15

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05159427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Study Contact

Zerick Dill, MS

CONTACT

7346475984

zerick@med.umich.edu

Amit Pai, PharmD

CONTACT

7346470006

amitpai@med.umich.edu

Principal Investigator

Arsalan Zafar Iqbal, MBBS

STUDY_DIRECTOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Arsalan Zafar Iqbal, MBBS, STUDY_DIRECTOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-15

Study Completion Date2026-09

Study Record Updates

Study Start Date2022-03-15

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

Clinical study
Glipizide
Modified release
Pharmacokinetics
In vivo dissolution
Local gastrointestinal concentration

Additional Relevant MeSH Terms

Human Gastrointestinal Physiology Data