Clinical Trials Logo

Clinical Trial Summary

This study was a pharmacokinetic and safety evaluation of the S-adenosylmethionine formulation MSI-195, and a commercial comparator. The study was broken into two stages. The first stage was an exploratory single ascending dose design of MSI-195 in 8 healthy normal male volunteers. The second stage was a single dose evaluation, targeting 26 male and female volunteers at set doses of MSI-195 and commercial comparator in a cross-over design followed by a food effect study on MSI-195. Plasma samples were collected and assayed for S-adenosylmethionine. Pharmacokinetic parameters were calculated using that data.


Clinical Trial Description

The study was focussed on the safety and pharmacokinetic evaluation of MSI-195; a novel patented formulation of S-adenosylmethionine. MSI-195 is a 400 mg dosage strength, tablet formulation comprising a core tablet, a seal coat and an enteric coat. The commercial comparator is SAM-e CompleteTM, manufactured by Pharmavite under the NatureMadeTM brand. This study consisting of two stages. The first stage was an exploratory single ascending dose design of MSI-195 in 8 healthy normal male volunteers. The second stage was a more comprehensive single dose evaluation, targeting 26 male and female volunteers at set doses of MSI-195 and commercial comparator in a cross-over design followed by a food effect study on MSI-195. Stage 1 design In each period of this stage of the study, ascending single doses of 400 mg, 800 mg and 1600 mg of MSI-195 was orally administered under fasted conditions, followed by 24 hours of blood draws at periodic intervals for the determination of plasma concentration of S-adenosylmethionine in a repeated-measure design. The drug administrations were separated by a wash-out of 7 calendar days. Stage 2 design In the first 2 periods of this stage of the study, a single 800 mg dose of MSI-195 and a single 1600 mg dose of commercial comparator were orally administered under fasted conditions, in a 2-way crossover design. During the 3rd period, a single 800 mg dose of MSI-195 was administered under fed conditions to all subjects. The drug administrations were separated by a wash-out of 7 calendar days. For each dosing, subjects had periodic blood draws over a 24 hour period to determine the plasma concentration of S-adenosylmethionine as a function of time. Male and female volunteers were included in the study. Subjects were in good health as determined by a medical history, complete physical examination (including vital signs), electrocardiogram (ECG), neurological examination and a panel of clinical laboratory tests. Blood samples were collected and stored frozen until assayed. The samples were assayed for S-adenosylmethionine using a validated HPLC method with MS/MS detection. For pharmacokinetic assessments, the main absorption and disposition parameters were calculated using a non-compartmental approach with a log-linear terminal phase assumption. The pharmacokinetic parameters of this trial were Cmax, Tmax, AUCT, AUC∞, AUCT/∞, Kel and T½el. The safety parameters assessed included the occurrence of adverse events, the measurement of clinical laboratory parameters, vital signs, neurological function tests, physical examination and ECG ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04623034
Study type Interventional
Source MSI Methylation Sciences, Inc.
Contact
Status Completed
Phase Phase 1
Start date April 17, 2013
Completion date June 8, 2013

See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4