Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02675660|
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : September 8, 2016
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: L-Homoarginine Drug: Placebo||Phase 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.
- Study Duration One year
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Study to Evaluate the Safety, Tolerability, Kinetics, and Dynamics of Single and Multiple Doses of an Oral Formulation of L-Homoarginine|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||January 2016|
125 mg of L-homoarginine
Dietary Supplement: L-Homoarginine
125 mg L-homoarginine once daily
Placebo Comparator: Placebo
placebo capsules once daily
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 1 Month ]To determine the AUC of L-homoarginine (a) following a single oral dose and (b) following administration of multiple oral doses of L-homoarginine.
- Peak plasma concentration (Cmax) [ Time Frame: 1 Month ]To determine the Cmax of L-homoarginine (a) following a single oral dose and (b) following administration of multiple oral doses of L-homoarginine.
- Half life of plasma concentration (t1/2) [ Time Frame: 1 Month ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||20 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675660
|Principal Investigator:||Rainer H Böger, Prof. Dr.||UHHamburg Eppendorf|
|Responsible Party:||Universitätsklinikum Hamburg-Eppendorf|
|Other Study ID Numbers:||
|First Posted:||February 5, 2016 Key Record Dates|
|Last Update Posted:||September 8, 2016|
|Last Verified:||September 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|