MK-0616 (Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020)
Hypercholesterolaemia
About this trial
This is an interventional treatment trial for Hypercholesterolaemia
Eligibility Criteria
Inclusion Criteria: Be in good health with the exception of renal impairment (RI) and hypercholesterolemia for participants in Panels A, B, and C. Participants with RI that have stable, chronic medical or psychiatric conditions, including but not limited to hypertension, hypercholesterolemia, diabetes mellitus, hyper- or hypothyroidism, gout, and chronic anxiety or depression may be included at the discretion of the investigator. Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 40 kg/m2, inclusive Be on a stable dose of any statin therapy defined as: no changes to dose or type of statin therapy for at least 2 months prior to Screening and participant anticipates no changes to statin therapy throughout the study until the poststudy visit Exclusion Criteria: History or presence of renal artery stenosis. Had a functioning renal transplant in the past 5 years and is taking transplant medication. Participants in panels A, B and D: Has rapidly fluctuating renal function as determined by historical measurements Has a history gastrointestinal disease which might affect food and drug absorption, as determined by the investigator, or has had gastric bypass or similar surgery History of cancer (malignancy) History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food Has received an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) small molecule treatment, monoclonal antibody, or short interfering RNA (siRNA) or RNA interference (ie, Inclisiran) within 12 months prior to Screening Participants with RI (Panels A, B, and C): Taking medications to treat chronic medical conditions and/or conditions associated with renal disease, if participant has not been on a stable regimen for at least 1 month (other than statins, which require a stable dose for at least 2 months) prior to administration of the initial dose of study intervention, and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 4 hours after administration of study intervention Participated in another investigational study within 4 weeks prior to the prestudy (screening) visit Consumes greater than 3 servings of alcoholic beverages per day Consumes excessive amounts, defined as greater than 6 servings of caffeinated beverages per day
Sites / Locations
- Velocity Clinical Research, Hallandale Beach ( Site 0003)Recruiting
- Clinical Pharmacology of Miami ( Site 0005)Recruiting
- Advanced Pharma CR, LLC ( Site 0001)Recruiting
- Orlando Clinical Research Center ( Site 0004)Recruiting
- Genesis Clinical Research, LLC ( Site 0002)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Panel A: Moderate Renal Impairment (RI)
Panel B: Severe RI
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
Panel D: Healthy
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days). Period 2 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 2 = 15 days). A washout period of 14 days will separate Period 1 and Period 2.
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)