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Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03296800
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Theracos

Brief Summary:
The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with three commonly prescribed medications, probenecid, verapamil or rifampin. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when taken with probenecid, verapamil or rifampin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Bexagliflozin Drug: Probenecid Drug: Rifampin Drug: Verapamil Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Non-Randomized, Fixed-Sequence Composite Study to Evaluate the Effects of Probenecid, Rifampin, and Verapamil on the Pharmacokinetics and Pharmacodynamics of Bexagliflozin in Healthy Subjects
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bexagliflozin/probenecid Drug: Bexagliflozin
Bexagliflozin 20 mg, tablet; qd
Other Name: EGT0001442, EGT0001474

Drug: Probenecid
Probenecid tablets, 500 mg; bid

Experimental: Bexagliflozin/rifampin Drug: Bexagliflozin
Bexagliflozin 20 mg, tablet; qd
Other Name: EGT0001442, EGT0001474

Drug: Rifampin
Rifampin, 600 mg (2 x 300 mg capsules); qd

Experimental: Bexagliflozin/verapamil Drug: Bexagliflozin
Bexagliflozin 20 mg, tablet; qd
Other Name: EGT0001442, EGT0001474

Drug: Verapamil
Verapamil hydrochloride tablet, 120 mg; qd




Primary Outcome Measures :
  1. Cmax (Maximum observed plasma concentration) [ Time Frame: Up to 48 hours ]
    Cmax of bexagliflozin

  2. Tmax (Time of maximum observed plasma concentration) [ Time Frame: Up to 48 hours ]
    Tmax of bexagliflozin

  3. T1/2 (Apparent terminal elimination half-life) [ Time Frame: Up to 48 hours ]
    T1/2 of bexagliflozin

  4. AUC0-inf (Area under the plasma concentration-time curve from Time 0 to infinity) [ Time Frame: Up to 48 hours ]
    AUC0-inf of bexagliflozin


Secondary Outcome Measures :
  1. Urinary Glucose Excretion 0-24 hr [ Time Frame: 0-24 hours ]
  2. Urinary Glucose Excretion 24-48 hr [ Time Frame: 24-48 hours ]
  3. Safety as measured by adverse events [ Time Frame: Up to 2 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
  2. Subjects who have not used tobacco for at least 3 months before screening
  3. Subjects who are willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic
  4. Subjects who are willing and able to be confined to the clinical research facility as required by the protocol

Exclusion Criteria:

  1. Subjects with a clinically significant history of allergy to drugs or latex
  2. Subjects with a history of alcohol or drug dependence in the past 12 months.
  3. Subjects who have donated a significant amount of blood in the past 2 months
  4. Female subjects who are pregnant or breastfeeding
  5. Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
  6. Subjects who had previously taken probenecid, rifampin or verapamil within 3 months of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296800


Locations
United States, Florida
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Theracos
Investigators
Study Director: Mason Freeman, M.D. Massachusetts General Hospital

Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT03296800     History of Changes
Other Study ID Numbers: THR-1442-C-454
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rifampin
Verapamil
Probenecid
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents