NCT02675660

Brief Summary

This study represents an initial clinical evaluation of an oral formulation of L-homoarginine. L-homoarginine and L-arginine are amino acids found in food proteins and are both substrates for nitric oxide synthase (NOS). L-arginine is available as over the counter nutraceutical. This study will provide information on the dosing of L-homoarginine in order to reach high physiological plasma concentrations in humans.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

January 13, 2016

Last Update Submit

September 6, 2016

Conditions

Healthy

Keywords

kinetic datavolunteers

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC)

    To determine the AUC of L-homoarginine (a) following a single oral dose and (b) following administration of multiple oral doses of L-homoarginine.

    1 Month

Secondary Outcomes (2)

  • Peak plasma concentration (Cmax)

    1 Month

  • Half life of plasma concentration (t1/2)

    1 Month

Study Arms (2)

L-Homoarginine

EXPERIMENTAL

125 mg of L-homoarginine

Dietary Supplement: L-Homoarginine

Placebo

PLACEBO COMPARATOR

placebo capsules

Drug: Placebo

Interventions

L-HomoarginineDIETARY_SUPPLEMENT

125 mg L-homoarginine once daily

L-Homoarginine
PlaceboDRUG

placebo capsules once daily

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 20-75 years of age on the day of dosing and is generally healthy as determined by medical history, physical examination, and laboratory test values
  • For females, postmenopausal for at least 2 years prior to screening (confirmed by a negative hormone panel, i.e., plasma 17β-estradiol concentration of \<20 pg/mL and follicle-stimulating hormone level of \>40 IU/mL) or contraception
  • Has signed and received a copy of the written informed consent form approved by the investigator's Independent Ethics Committee (IEC), understands the purposes and risks of the study and agrees to follow the restrictions and schedule of procedures as defined by the study protocol

You may not qualify if:

  • Sitting blood pressure greater than 160/100 or less than 90/60 mm Hg
  • Sitting heart rate greater than 99 bpm or less than 50 beats per minute (bpm)
  • History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness
  • Body Mass Index (BMI) greater than 32 or less than 16 at screening \[BMI = Weight (kg) ÷ Height2 (m2)\]
  • History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias,or congestive heart failure
  • History of significant central nervous system disease, including transient ischemic attack, stroke, seizure disorder, or behavioral disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Atzler D, Schwedhelm E, Choe CU. L-homoarginine and cardiovascular disease. Curr Opin Clin Nutr Metab Care. 2015 Jan;18(1):83-8. doi: 10.1097/MCO.0000000000000123.

    PMID: 25474016BACKGROUND

  • Atzler D, Schonhoff M, Cordts K, Ortland I, Hoppe J, Hummel FC, Gerloff C, Jaehde U, Jagodzinski A, Boger RH, Choe CU, Schwedhelm E. Oral supplementation with L-homoarginine in young volunteers. Br J Clin Pharmacol. 2016 Dec;82(6):1477-1485. doi: 10.1111/bcp.13068. Epub 2016 Sep 20.

    PMID: 27434056BACKGROUND

MeSH Terms

Interventions

omega-N-aminohomoarginine

Study Officials

  • Rainer H Böger, Prof. Dr.

    UHHamburg Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

February 5, 2016

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

January 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share