Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects
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|ClinicalTrials.gov Identifier: NCT02675660|
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : September 8, 2016
|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.
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|