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
Sponsor study identifier
interventional
34
0 countries
N/A
Study Start
April 17, 2013
Actual (reported)Primary Completion
June 8, 2013
Actual (reported)Study Completion
June 8, 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 8, 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 17, 2013
Actual (reported)June 8, 2013
Actual (reported)June 8, 2013
Actual (reported)October 30, 2020
Actual (reported)November 10, 2020
Actual (reported)Incidence and severity of treatment-related adverse events (safety and tolerability) as measured by vital signs, ECG, laboratory tests, neurological function tests, and the occurance of adverse events
Incidence and severity of treatment-related adverse events determined by changes from screening (baseline) of findings from physical examination, vital signs, ECG, laboratory tests, neurological function tests, and the occurance of adverse events.
for 24 hours after dosing
Pharmacokinetics was evaluated by measuring the systemic plasma concentration of ademetionine
plasma concentrations of ademetionine were measured as a function of time using a validated bioanalytical assay
for 24 hours after dosing
400 mg MSI-195 (within Stage 1, single ascending dose)
800 mg MSI-195 (within Stage 1, single ascending dose)
1600 mg MSI-195 (within Stage 1, single ascending dose)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cameron BR, Ferreira L, MacDonald ID. Pharmacokinetic study of a novel oral formulation of S-adenosylmethionine (MSI-195) in healthy subjects: dose escalation, food effect and comparison to a commercial nutritional supplement product. BMC Pharmacol Toxicol. 2020 Dec 14;21(1):88. doi: 10.1186/s40360-020-00466-7.
Eric Sicard, M.D.
Algorithme Pharma Inc
34 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2020
First Posted
November 10, 2020
Study Start
April 17, 2013
Actual (reported)A Study to Investigate the Effect of JNJ-42847922 on Polysomnography Measures in Patients With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
800 mg MSI-195 fed (within Stage 2, cross-over comparison)
1600 mg SAM-e Complete (within Stage 2, cross-over comparison)
800 mg MSI-195- fed (within Stage 2, fed arm)
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Primary Completion
June 8, 2013
Actual (reported)Study Completion
June 8, 2013
Actual (reported)Last Updated
November 10, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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