NCT04623034

Evaluation of the Safety and Pharmacokinetics of MSI-195 to a Commercial S-Adenosylmethionine

A Phase 1, Two Stage, Open Label, Randomized, Single Dose, Comparative Study to Evaluate the Safety and Pharmacokinetics of MSI-195 to a Commercial S-Adenosylmethionine Product in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: MSI Methylation Sciences, Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Ademetionine

Timeline

• Start date: 2013-04-17
• Primary completion: 2013-06-08
• Completion: 2013-06-08
• First posted: 2020-11-10
• Last updated: 2020-11-10

Regulatory

• FDA-regulated drug study