CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 2 enrolled
Drug / intervention
C-13 labeled Lysine +1 moredrug
Likely dose
C-13 labeled lysine bolus (specific dose not stated)AI-extracted
Key inclusion· 2
  • Age 18-45 years
  • BMI 18 to <25 kg/m2
Key exclusion· 10
  • Current prescription medications (except hormonal birth control)
  • Amino acid supplements or supplemental protein; unwilling to discontinue 1 week prior
  • Tobacco use in past 30 days
  • Prior or current cardiovascular, renal, or liver disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03063476
NCT03063476Phase 1Completed

The Effect of Acute Lysine Administration on α-aminoadipic Acid

Vanderbilt University Medical Center·interventional·Posted Feb 24, 2017·Updated Dec 19, 2018

In Brief

A Phase 1 clinical trial evaluating C-13 labeled Lysine and Normal saline for Healthy. Completed, enrolled 2 participants across 1 site.

Detailed Summary

This sub-study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 24, 2017
Enrollment StartMar 1, 2017
Primary CompletionMay 18, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.4 years ago

Interventions

C-13 labeled Lysinedrug

Carbon-13 is a stable naturally occurring heavy isotope of carbon. Inclusion of a 13C label on lysine allows for subsequent differentiation between endogenous and exogenous lysine and 2-AAA for calculation of clearance and excretion of the lysine bolus.

Normal salinedrug

Because patients will have multiple blood draws during the course of the study, subjects will have an IV placed to reduce the number of needle sticks. To keep the vein open for blood collections, we will infuse Normal (0.9%) Saline (NS) at a rate of approximately 10ml/hr in order to keep the line open.