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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Criteria

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:

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