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

  • STATUS
    Recruiting
  • End date
    Sep 11, 2023
  • participants needed
    40
  • sponsor
    University of Michigan
Updated on 11 April 2022
Accepts healthy volunteers

Summary

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. Also collection of physiologic data (such as pressure, temperature and GI transit time) from GI tract through an electronic pill taken by mouth called SmartPill.

Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

Description

This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from healthy subjects which are necessary for mechanistic absorption model development. Each subject will be asked to complete two phases. The first phase will include collection of fluids from stomach and gastrointestinal (GI) tract through intubation (putting a GI tube from mouth into stomach and intestines), blood, urine and feces, and measure glipizide concentrations.

The second phase will not involve the intubation procedure. Instead, An electronic pill called SmartPill will be used. The pill is swallowed by mouth and collects physiologic data (such as pressure, temperature and GI transit time) as it travels through GI tract. Blood, urine and feces, will also be collected for measurement of glipizide concentrations. A minimum of 5 days will separate each of the two study phases. The objectives of this study are, as follows: Objective #1: To characterize the plasma, gastrointestinal fluid, urine, and feces concentrations of glipizide after oral administration of modified release formulations; Objective #2: To compare the pharmacokinetics of glipizide between the two modified release formulations; Objective #3: To compare the pharmacokinetics of glipizide with and without gastrointestinal intubation; Objective #4: To collect gastrointestinal physiology data in volunteers receiving an oral MR formulation of glipizide. These in vivo results will be used to validate in vitro dissolution methods and to support computational and mathematical modeling efforts, in order to develop an oral drug product optimization process that may be applied to future drugs to maximize oral drug safety and efficacy.

Details
Condition Human Gastrointestinal Physiology Data
Treatment Glucotrol XL 5Mg Extended-Release Tablet, Glipizide ER 5 MG 24 HR Extended Release Oral Tablet, Rifaximin 200Mg Tab, 13C6-Glipizide
Clinical Study IdentifierNCT05159427
SponsorUniversity of Michigan
Last Modified on11 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Unable to independently provide an informed consent for themselves or mentally incapacitated
Physical disability (including blindness or deafness) that requires special arrangements
Significant clinical illness, including cardiovascular disease, neurological disease, organ failure, or malignancy in the opinion of the investigator
Any surgical procedure within 3 weeks prior to screening
History and/or presence of severe seasonal allergies or severe allergic diseases including drug allergies, food allergies and allergy against the SmartPill® device
History and/or presence of hypersensitivity to any of the study drugs or the products' excipients
History and/or presence of hypersensitivity to Sulfonamide derivatives
History and/or presence of hypersensitivity to Lidocaine
History and/or presence of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of XIFAXAN
History and/or presence of hypersensitivity to acrylate or methacrylate, commonly used components of medical adhesives
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
Subjects with Type 1 Diabetes Mellitus (DM), diabetic ketoacidosis, with or without coma
Subjects with Glucose 6-phosphate dehydrogenase (G6PD) deficiency
History and/or presence of drug addiction or alcohol abuse within the past 12 months
History of significant psychiatric or neurological illness, including seizure disorders
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)
History of dysphagia to liquids, food, or pills
History of abdominal radiation therapy
Pregnant or lactating females
Any clinically significant abnormal lab values during screening in the opinion of the investigator
Use of alcohol and/or nicotine containing products 48 hours prior to dosing visits, and throughout PK sampling visits
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)
Use of aspirin or any blood thinner medications
Use of an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
Volunteers unwilling or unable to take the proposed drugs or undergo G.I intubation
Enrollment in a clinical trial in the past 30 days
Current enrollment in a clinical trial with another study drug, vaccine or medical device
Fasting blood glucose level < 80 mg/dL
Inability or unwillingness to fast for 19 hours
Blood donations in the past 8 weeks except for apheresis
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
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
Volunteer has been in close contact in the last 14 days with someone recently
diagnosed with COVID-19
Volunteer has returned from international travel within the past 10 days
Clear my responses

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