Trial Outcomes & Findings for The Effect of Acute Lysine Administration on α-aminoadipic Acid (Sub-study) (NCT NCT03063476)

NCT ID: NCT03063476

Last Updated: 2018-12-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 2 participants
• Primary outcome timeframe: Baseline and 2-6 hours
• Results posted on: 2018-12-19

Participant Flow

Healthy subjects (N=2) were recruited in March 2017. Subjects who had previously participated in a pilot study were invited to return for an additional study visit.

Participant milestones

Measure	Healthy Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Healthy n=2 Participants Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2-6 hours

Population: Two healthy subjects (one male, one female; one black, one white) were enrolled and completed the study visit.

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

Outcome measures

Measure	Healthy n=2 Participants Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
Peak Plasma 2-AAA Concentration Percentage Change From Baseline	63.4 Percentage Change Standard Deviation 55

SECONDARY outcome

Timeframe: Baseline and 2-6 hours

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

Outcome measures

Measure	Healthy n=2 Participants Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
Peak Urinary 2-AAA Concentration Percentage Change From Baseline	39 Percentage change Standard Deviation 99

Adverse Events

Healthy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy n=2 participants at risk Two healthy subjects will be enrolled and each will undergo the same study procedures at one visit.
Gastrointestinal disorders Mild Nausea	50.0% 1/2 • Number of events 1 • Adverse events were collected from 0-6 hours during the study visit.

Additional Information

Dr. Jane Ferguson

Vanderbilt University Medical Center

Phone: 6158759896

Email: jane.f.ferguson@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place