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

NCT03063476 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 160520-1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Peak Plasma 2-AAA Concentration Percentage Change From Baseline

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

  Baseline and 2-6 hours

Secondary Outcomes (1)

• Peak Urinary 2-AAA Concentration Percentage Change From Baseline

  Baseline and 2-6 hours

Study Arms (1)

Healthy

EXPERIMENTAL

Two healthy subjects will be enrolled and each will undergo study procedures at one visit. After screening and consent have been conducted over the phone, subjects will participate in the study procedures. Subjects will arrive in a fasting state (no eat or drink for 8 hours, excluding water). Following collection of blood pressure, height, weight, and a urine and blood sample, subjects will be given an oral bolus of C-13 labeled lysine (5 g) in 50 ml water. This amount of lysine is equivalent to that which is found in a 5oz. serving of beef. Subjects will provide additional urine and blood samples serially post-ingestion. Because blood draws will be collected through an IV, Normal (0.9%) Saline (NS) will be infused at a rate of approximately 10 ml/hr to flush the canula prior to each blood draw. All subjects will undergo the same procedures and interventions.

Drug: C-13 labeled Lysine; Drug: Normal saline

Interventions

C-13 labeled Lysine DRUG

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.

Healthy

Normal saline DRUG

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.

Also known as: Normal (0.9%) Saline (NS)

Healthy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18 to \<25 kg/m2
• Men and women ages 18-45 years

You may not qualify if:

• Current use of prescription medications (apart from hormonal birth control)
• Current use of amino acid supplements (including branched-chain amino acids) or supplemental protein (habitual consumption of protein powder, bars, shakes), and unwilling to temporarily discontinue use (1 week prior to study visit)
• Individuals who currently use tobacco products or have done so in the previous 30 days
• Prior or current cardiovascular disease, renal disease, or liver disease
• Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled)
• Atrial fibrillation
• Bleeding disorder or anemia
• Positive pregnancy test
• Women who are breastfeeding
• Participation in another clinical trial within the previous 6 weeks prior to the study visit
• Inability to provide written informed consent
• Inability to fast for 8 hours

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jane Ferguson
• Organization: Vanderbilt University Medical Center

jane.f.ferguson@vanderbilt.edu

6158759896

Study Officials

• Jane F Ferguson, PhD

  Vanderbilt Cardiovascular Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: March 1, 2017
• Primary Completion: May 18, 2017
• Study Completion: May 18, 2017
• Last Updated: December 19, 2018
• Results First Posted: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)