MK-0822
DrugA single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
Other names: odanacatib
NCT Number: NCT01512667
This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib administered to participants with impaired renal/kidney function to those of a healthy matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose.
Looking for future studies?
Notify Me18 year–79 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion Criterion Specific to Participants with Renal/Kidney Insufficiency:
Inclusion Criterion Specific to Healthy Volunteers:
Exclusion criteria
A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
Other names: odanacatib
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.
Merck Sharp & Dohme LLC
Industry
A Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Renal Insufficiency
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05936138
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Miami, Florida, United States
View Trial DetailsNCT06890208
Anxiety Disorders, Arrhythmias, Cardiac
Hamburg, Germany
View Trial DetailsNCT04876963
Arrhythmias, Cardiac, Cardiovascular Diseases
Copenhagen, Denmark
View Trial DetailsNCT07165015
Chronic Disease, Disease Attributes
Orlando, Florida, United States
View Trial Details