A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)
NCT ID: NCT00830791
Last Updated: 2015-02-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
32 participants
INTERVENTIONAL
2009-01-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
NCT01131091
STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT
NCT04616027
A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function
NCT06370819
A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function
NCT00501462
A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney Problems
NCT03723785
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MK-0941 20 mg Mild Renal Insufficiency
MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes.
MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
MK-0941 20 mg Moderate Renal Insufficiency
MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes.
MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
MK-0941 5 mg Severe Renal Insufficiency
MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes.
MK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.
MK-0941 20 mg Matched Controls
MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes.
MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
MK-0941 5 mg Matched Controls
MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.
MK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
MK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female of childbearing potential on appropriate method of contraception
* Body mass index (BMI) less than or equal to 40 kg/m2
* Participant is in good health
* Participant diagnosed with Type 2 Diabetes
* Participant agrees to follow smoking restrictions
* Willing to follow the study diet restrictions
Exclusion Criteria
* Participant has had kidney removed
* History of Type 1 diabetes
* History of stroke, chronic seizures or major neurological disorder
* History of neoplastic disease
* Nursing mother
* Consumes greater than 4 glasses of alcoholic beverages per day
* Consumes greater than 6 servings of caffeinated beverages per day
* Participant has had surgery or donated 1 unit of blood within 1 month of screening
* Participant has history of recent eye infection within 2 weeks of study drug administration
* Clinically diagnosed with glaucoma or blindness
* Has trauma to one or both eyes
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009_522
Identifier Type: -
Identifier Source: secondary_id
0941-015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.