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Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02291510
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : September 21, 2015
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Elcelyx Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Results First Submitted Date  ICMJE August 21, 2015
Results First Posted Date  ICMJE September 21, 2015
Last Update Posted Date December 2, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • AUC (0-t) of Plasma Metformin [ Time Frame: Time points to create AUC (0-t) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner. ]
    AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration after the standardized dinner. Doses were administered 1 min prior to 0 h (standardized dinner) for once daily in the evening (qPM) and twice daily (BID) dosing and 1 min prior to 12 h (standardized breakfast) for once daily in the morning (qAM) and BID dosing.
  • Cmax of Plasma Metformin [ Time Frame: Time points to create Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner. ]
    Cmax = Maximum concentration from the first dose of study medication administration (0 h) to the time of the last quantifiable concentration following dose administration. Doses were administered 1 min prior to 0 h (standardized dinner) for qPM and BID dosing and 1 min prior to 12 h (standardized breakfast) for qAM and BID dosing.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
AUC(0-t) [ Time Frame: 36 hours after first dose ]
Change History Complete list of historical versions of study NCT02291510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects
Official Title  ICMJE A Randomized, Crossover Study Assessing the Pharmacokinetics of EFB0027 Versus ETB0015 and ETB0014 in Healthy Subjects
Brief Summary This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR, ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: Met DR
    metformin delayed-release tablets
  • Drug: Met XR
    metformin extended-release tablets
  • Drug: Met IR
    metformin immediate-release tablets
Study Arms  ICMJE
  • Experimental: 500 mg Met DR BID
    Two doses of 500 mg metformin delayed-release
    Intervention: Drug: Met DR
  • Experimental: 1000 mg Met DR BID
    Two doses of 1000 mg metformin delayed-release
    Intervention: Drug: Met DR
  • Active Comparator: 1000 mg Met IR BID
    Two doses of 1000 mg metformin immediate-release
    Intervention: Drug: Met IR
  • Active Comparator: 2000 mg Met XR QD
    Single dose of 2000 mg metformin extended-release
    Intervention: Drug: Met XR
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2014)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 19 to 65 (inclusive) years old at Visit 1 (Screening)
  2. Male, or if female and met all of the following criteria:

    1. Not breastfeeding
    2. Negative pregnancy test result at Visit 1 (Screening) (not applicable to hysterectomized females)
    3. Surgically sterile, postmenopausal, or if of childbearing potential, practiced and was willing to continue to practice appropriate birth control during the entire duration of the study
  3. Body mass index (BMI) of 25.0 to 35.0 kg/m² (inclusive) at Visit 1 (Screening)
  4. Had a physical examination with no clinically significant abnormalities as judged by the investigator
  5. Had normal renal function with an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation
  6. Ability to understand and willingness to adhere to protocol requirements

Exclusion Criteria:

  1. Had a clinically significant medical condition as judged by the investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions:

    1. Hepatic disease
    2. Gastrointestinal disease
    3. Endocrine disorder (including diabetes and impaired glucose tolerance)
    4. Cardiovascular disease
    5. Central nervous system diseases
    6. Psychiatric or neurological disorders
    7. Organ transplantation
    8. Chronic or acute infection
    9. Orthostatic hypotension, fainting spells or blackouts
    10. Allergy or hypersensitivity
  2. Had any chronic disease requiring medication that was adjusted in the past 90 days (subjects could take acute intermittent over-the-counter medications such as Tylenol, if needed)
  3. Had major surgery of any kind within 6 months of Visit 1 (Screening)
  4. Had a history of >6 kg weight change within 3 months of Visit 1 (Screening)
  5. Had clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities judged by the investigator to be clinically significant at Visit 1 (Screening)
  6. Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
  7. Had any drug treatment that affects gastric pH (prescription or over-the-counter), including any antacids or medications such as Rolaids or Pepcid within 2 days of Visit 1 (Screening)
  8. Currently abused drugs or alcohol or had a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures
  9. Smoked more than 10 cigarettes per day, 3 cigars per day, 3 pipes per day, used more than 1 can of smokeless tobacco per week, or used a combination of tobacco products that approximate nicotine doses equivalent to 10 cigarettes per day
  10. Had donated blood within 3 months of the date of the first dose of randomized study medication, or was planning to donate blood during the study
  11. Had received any investigational drug within 2 months (or five half-lives of the investigational drug, whichever was greater) of the date of the first dose of randomized study medication
  12. Had known allergies or hypersensitivity to any component of study treatment
  13. Was employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract worker, or designee of the company)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291510
Other Study ID Numbers  ICMJE LCRM103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elcelyx Therapeutics, Inc.
Study Sponsor  ICMJE Elcelyx Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Rasmussen, MD Celerion
PRS Account Elcelyx Therapeutics, Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP