The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.
During Part 1, eligible subjects will be asked to participate in 3 inpatient visits, each lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of \[1-13C\]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis. During Part 2, eligible subjects will be asked to participate in 1 inpatient visit, lasting up to 3 days (Day -1 to Day 2). The visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of \[1-13C\]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis.
Study Type
OBSERVATIONAL
Enrollment
120
No intervention
PPD Phase 1 Unit
Austin, Texas, United States
Plasma Ammonia Area Under the Curve (AUC0-24)
Characterization of ammonia production over 24hr
Time frame: Part 1, Day 1 (Visits 1-3) and Part 2, Day 1:Predose (0hour) up to 24 hours post dose
Rate of Ureagenesis Based On Presence of [1-13C] In Urea
Characterization of nitrogen flux as determined by production of urea. Sodium acetate is used as a tracer to measure the rate of ureagenesis.
Time frame: Part 1, Day 1 (Visits 1-3) and Part 2, Day 1: Predose (0hour) up to 4 hours post dose
Intra- and inter-subject coefficient of variation (CV) of AUC0-24 and Rate of Ureagenesis
Comparative analysis of both parameters
Time frame: Part 1 Treatment Period: 17 days; Part 2 Treatment Period: 3 days
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