A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects

A Single-Center Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve From Time Zero to 24 Hours and Rate of Ureagenesis in Healthy Adult Subjects

Sponsors

Lead Sponsor: Ultragenyx Pharmaceutical Inc

Source Ultragenyx Pharmaceutical Inc
Brief Summary

The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.

Detailed Description

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.

Overall Status Completed
Start Date 2019-08-02
Completion Date 2020-02-20
Primary Completion Date 2020-02-20
Study Type Observational
Primary Outcome
Measure Time Frame
Plasma Ammonia Area Under the Curve (AUC0-24) 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 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 Part 1 Treatment Period: 17 days; Part 2 Treatment Period: 3 days
Enrollment 120
Condition
Intervention

Intervention Type: Other

Intervention Name: No Intervention

Description: No intervention

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Body mass index between 18 and 30 kg/m2, inclusive. Exclusion Criteria: - History of liver disease as evidenced by any of the following: portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy, or a liver biopsy with evidence of stage 3 fibrosis. - Significant hepatic inflammation or cirrhosis as evidenced by imaging or any of the following laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than the upper limit of normal (ULN), total bilirubin >1.5 × ULN, alkaline phosphatase >2.5 × ULN. NOTE: the ALT and/or AST levels may be repeated. - Subject has a history of gout. - Plasma ammonia level that is not within normal limits at Screening in the opinion of the Investigator or Sponsor. - Received any vaccine within 14 days prior to Screening. - Pregnant, lactating, or intending to become pregnant at any time during the study. - Blood transfusion within 8 weeks prior to Screening.diuretics, cyclophosphamide and other cytotoxic agents, tolbutamide, chlorpropamide, diazoxide, dichlorphenamide, pyrazinamide, probenecid, theophylline/aminophylline, riluzole, warfarin and other antithrombotic agents, supplements containing aluminum hydroxide, or iron supplements within 30 days of Part 1or Part 2.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

55 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Medical Director Study Director Ultragenyx Pharmaceutical
Location
Facility: PPD Phase 1 Unit
Location Countries

United States

Verification Date

2020-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Part 1

Description: 30 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.

Label: Part 2

Description: 90 eligible subjects will be asked to participate in 1 inpatient visit, 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.

Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Cross-Sectional

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