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CompletedNCT02675660Updated Sep 8, 2016

Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects

A Phase 1 interventional study of L-Homoarginine and Placebo in Healthy, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-08.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description
  1. Study Design In a randomized, double-blind, placebo-controlled cross-over design participants receive either L-homoarginine 125 mg or placebo once daily in the morning for four weeks each. The study periods are separated by a washout phase of four weeks, and the sequence of the medications is randomly chosen in each participant. The study is preceded by a run-in phase, where all participant receive a single dose of 125 mg L-homoarginine. Blood samples (2.7 ml ethylenediaminetetraacetic acid vacutainer) for plasma L-homoarginine determinations are drawn at time points 0, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, and 120 hours after single and multiple doses of L-homoarginine and placebo, respectively. At baseline and four weeks after each supplementation period (hArg and placebo), routine laboratory, arginine, asymmetric dimethylarginine, pulse wave velocity, augmentation index, flow-mediated vasodilatation, transcranial magnetic stimulation, and test battery of attentional performance are evaluated as secondary endpoints.
  2. Study Duration One year
  3. Sample Size Calculation and Statistical Evaluation Due to the exploratory nature of this pilot study, exploratory statistical methods will be used for statistical evaluation of the study results, and no formal sample size calculation was performed. In a previous study 20 participants were included to assess the kinetic, dynamic, and safety profile of L-citrulline and L-arginine [Schwedhelm et al. 2007]. Statistical comparisons will be performed using two-sided tests, i.e. Student's t-test and ANOVA. A p \< 0.05 will be considered significant.
02

Conditions studied

  • Healthy

Keywords

  • kinetic data
  • volunteers
03

In context

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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
  2. 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
  3. 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

Exclusion criteria

Exclusion Criteria:

  1. Sitting blood pressure greater than 160/100 or less than 90/60 mm Hg
  2. Sitting heart rate greater than 99 bpm or less than 50 beats per minute (bpm)
  3. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness
  4. Body Mass Index (BMI) greater than 32 or less than 16 at screening [BMI = Weight (kg) ÷ Height2 (m2)]
  5. History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias,or congestive heart failure
  6. History of significant central nervous system disease, including transient ischemic attack, stroke, seizure disorder, or behavioral disturbances
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    L-Homoarginine

    125 mg of L-homoarginine

    Dietary Supplement: L-Homoarginine

  • Placebo comparator
    Placebo

    placebo capsules

    Drug: Placebo

Interventions

  • Dietary supplementL-Homoarginine

    125 mg L-homoarginine once daily

  • DrugPlacebo

    placebo capsules once daily

06

What researchers measure

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.

    Time frame: 1 Month

Secondary outcomes

  1. Peak plasma concentration (Cmax)

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

    Time frame: 1 Month

  2. Half life of plasma concentration (t1/2)

    To determine the t1/2 of L-homoarginine (a) following a single oral dose and (b) following administration of multiple oral doses of L-homoarginine.

    Time frame: 1 Month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25474016 ↗
  • 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. PubMed 27434056 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02675660
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Feb 5, 2016
Start date
Apr 2014
Primary completion
Apr 2015
Completion
Jan 2016
Last update
Sep 8, 2016

Study contacts

Rainer H Böger, Prof. Dr.
principal investigator · UHHamburg Eppendorf

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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