Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623034
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2020-10-30
Brief Title:
Evaluation of the Safety and Pharmacokinetics of MSI-195 to a Commercial S-Adenosylmethionine
Sponsor:
MSI Methylation Sciences Inc
Organization:
MSI Methylation Sciences Inc
Study Overview
Official Title:
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
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 MSMS 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
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 MSMS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None