Status:
COMPLETED
Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects
Lead Sponsor:
Elcelyx Therapeutics, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
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-r...
Eligibility Criteria
Inclusion
- 19 to 65 (inclusive) years old at Visit 1 (Screening)
- Male, or if female and met all of the following criteria:
- Not breastfeeding
- Negative pregnancy test result at Visit 1 (Screening) (not applicable to hysterectomized females)
- 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
- Body mass index (BMI) of 25.0 to 35.0 kg/m² (inclusive) at Visit 1 (Screening)
- Had a physical examination with no clinically significant abnormalities as judged by the investigator
- 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
- Ability to understand and willingness to adhere to protocol requirements
Exclusion
- 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:
- Hepatic disease
- Gastrointestinal disease
- Endocrine disorder (including diabetes and impaired glucose tolerance)
- Cardiovascular disease
- Central nervous system diseases
- Psychiatric or neurological disorders
- Organ transplantation
- Chronic or acute infection
- Orthostatic hypotension, fainting spells or blackouts
- Allergy or hypersensitivity
- 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)
- Had major surgery of any kind within 6 months of Visit 1 (Screening)
- Had a history of \>6 kg weight change within 3 months of Visit 1 (Screening)
- Had clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities judged by the investigator to be clinically significant at Visit 1 (Screening)
- Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
- 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)
- 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
- 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
- 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
- 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
- Had known allergies or hypersensitivity to any component of study treatment
- Was employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract worker, or designee of the company)
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02291510
Start Date
October 1 2012
End Date
December 1 2012
Last Update
December 2 2016
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