NCT03063476

The Effect of Acute Lysine Administration on α-aminoadipic Acid (Sub-study)

Completed Phase 1 Results posted Last updated 19 December 2018

What this trial tests

Phase 1 trial testing C-13 labeled Lysine in Healthy in 2 participants. Completed in 18 May 2017.

Timeline

1 March 2017

Primary endpoint
18 May 2017

18 May 2017

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	2
Start date	1 March 2017
Primary completion	18 May 2017
Estimated completion	18 May 2017
Sites	1 location across United States

Drugs / interventions tested

• C-13 labeled Lysine — full drug profile →
• Normal saline

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peak Plasma 2-AAA Concentration Percentage Change From Baseline Primary · Baseline and 2-6 hours

Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified relative to standard.

Group	Value	95% CI
Healthy	63.4	± 55

Peak Urinary 2-AAA Concentration Percentage Change From Baseline Secondary · Baseline and 2-6 hours

Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified relative to standard.

Group	Value	95% CI
Healthy	39	± 99

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from 0-6 hours during the study visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Healthy

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (1 terms — click to expand)

Reaction	System	Healthy
Mild Nausea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03063476 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.