Study Assessing the Behavior of Delayed-Release Metformin in Subjects With Kidney Dysfunction
This trial is active, not recruiting.
|Sponsor||Elcelyx Therapeutics, Inc.|
|Start date||August 2013|
|End date||June 2014|
|Trial size||32 participants|
|Trial identifier||NCT01658514, LCRM101|
This study will evaluate how a single dose delayed-release metformin behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, and severe kidney dysfunction. The safety and tolerability of delayed-release metformin will also be examined.
In addition, this study will compare the behavior of a single dose of delayed-release metformin with that of extended-release metformin and placebo in subjects with the varying levels of kidney function described above.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Miami, FL||Clinical Pharmacology of Miami||no longer recruiting|
|Orlando, FL||Compass Research||no longer recruiting|
|Port Orange, FL||Prgressive Medical Research||no longer recruiting|
|Louisville, KY||Louisville Metabolic and Atherosclerosis Research Center||no longer recruiting|
|St Paul, MN||Prism Research||no longer recruiting|
|Endpoint classification||pharmacokinetics study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator)|
|Primary purpose||basic science|
Pharmacokinetics of delayed-release metformin
time frame: PK will be assessed over 3 days following a single dose; washout of 2 to 5 days until next administration
Characterize single dose exposure-response relationship of metformin and plasma lactate concentrations
time frame: Plasma lactate measures over 3 days following single dose administration; 2-5 days washout until next dose
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: 1. Is 18 to 80 (inclusive) years old at Visit 1 (Screening). 2. Is male, or is female and meets all of the following criteria: - Not breastfeeding - Negative pregnancy test result (human chorionic gonadotropin, beta subunit) at Visit 1 (Screening) (not applicable to hysterectomized females) - Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study - Has body weight of ≥ 45 kg 3. Has a BMI of 18.0 to 40.0 kg/m2 (inclusive) at Visit 1 (Screening). 4. Has type 2 diabetes mellitus and an HbA1c ≤10.0%. 5. Has a physical examination with no clinically significant abnormalities as judged by the investigator. 6. Has eGFR ≥15 mL/min/1.73 m2 based on the MDRD equation. 7. Ability to understand and willingness to adhere to protocol requirements Exclusion Criteria: 1. Has End Stage Renal Disease requiring dialysis or severe renal dysfunction with eGFR <15 mL/min/1.73 m2. 2. Is currently on dialysis or has been on dialysis within 12 months of Visit 1 (Screening). 3. Has received or plans to receive any iodinated contrast dye within 1 week prior to Visit 1 (Screening) or after study medication administration. 4. Is currently taking or has taken within 1 week of Visit 1 cationic drugs that are eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin). 5. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions: - Hepatic disease - Gastrointestinal disease - Endocrine disorder (type 2 diabetes mellitus is allowed) - 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 6. Has any chronic disease requiring medication that has been adjusted in the past 14 days(subjects may take acute intermittent over-the-counter medications such as Tylenol, if needed). 7. Has had major surgery of any kind within 6 months of Visit 1 (Screening). 8. Has a clinically significant finding of an electrocardiogram (ECG) as assessed by the investigator at Visit 1 (Screening). 9. Has clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities, other than those related to diabetes or renal disease and other stable diseases, judged by the investigator to be clinically significant at Visit 1 (Screening). 10. Has a hemoglobin result <8 g/dL or a level indicating severe anemia of renal origin. 11. Has physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study. 12. Has received Byetta® or short-acting insulin within 3 days of Visit 1 (Screening). 13. Has received metformin within 4 weeks of Visit 1 (Screening). 14. Has 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 2. 15. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures. 16. Smokes more than 10 cigarettes, 3 cigars, or 3 pipes per day. 17. Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate blood during the study. 18. Has received any investigational drug within one month (or seven half-lives of the investigational drug, whichever is greater) of Visit 1 (Screening). 19. Has known allergies or hypersensitivity to any component of study treatment. 20. Is employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract worker, or designee of the company).
|Official title||A Randomized, Crossover Study Assessing the Single Dose Pharmacokinetics of Delayed-Release Metformin in Subjects With Renal Dysfunction|
|Principal investigator||George Canas, MD|
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