A Phase 1 interventional study of MK-8931 in Alzheimer's Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931 in participants with severe renal disease and in healthy matched control participants will be studied. If data from Part 1 confirms that severe renal impairment does not alter the pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study will be required and Part 2 will be optional. If the data does not support this conclusion, then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with moderate and mild renal impairment compared to healthy matched controls.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Specific to Renally Impaired Participants:
Inclusion Criterion Specific to Healthy Participants:
Exclusion Criteria:
localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of recurrence ≥1 year post-therapy
Exclusion Criteria Specific to Renally Impaired Participants:
Drug: MK-8931
Drug: MK-8931
Drug: MK-8931
Drug: MK-8931
Drug: MK-8931
Drug: MK-8931
Single dose, administered as oral capsules
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931
Time frame: Predose through 120 hours post single dose of MK-8931
Renal clearance (CLr) of MK-8931
Time frame: Predose through 120 hours post single dose of MK-8931
Fraction of MK-8931 dose excreted in urine (fe)
Time frame: Predose through 120 hours post single dose of MK-8931
No study locations are listed for this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC