Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT02955693
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of the Organism on Monomethyl Fumarate (MMF) After the Administration of LAS41008
Sponsor:
Almirall, S.A.
Organization:
Study Overview
Official Title:
Randomized, Open-label, Single-center, Four-way Crossover, Single Dose Study to Investigate the Pharmacokinetics of LAS41008 120 mg Gastro-resistant Tablet and Fumaderm® 120 mg Gastro-resistant Tablet Under Fasting and Fed Conditions in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2016-12
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:
LAS41008
Brief Summary:
The purpose of this study is to determine how the organism affects MMF (metabolite of dimethyl fumarate \[DMF\]) after single oral dose administration of LAS41008 120 mg gastroresistant tablet and Fumaderm® 120 mg gastro-resistant tablet under fasting and fed conditions. The study also aims to assess the safety of the study treatments.
Detailed Description:
The present study will be conducted to further investigate the pharmacokinetics (PK) of LAS41008 (containing DMF) after single oral dose administrations of a 120 mg gastro-resistant tablet under fed and fasting conditions.
Two previous Phase 1 studies allowed exploring the PK of LAS41008 30 mg and 120 mg separately after multiple dosing. In the current study, an improved bioanalytical method will allow the detection of lower MMF concentrations, and thus the same gastro-resistant tablet formulation (LAS41008) as used in the previous Phase 1 study will be investigated, but on a larger population and after single oral dose administration. Only the higher LAS41008 dose (120 mg) will be tested, as this is the formulation to be most frequently used during a standard treatment course for psoriasis with LAS41008. Similarly, single oral doses of Fumaderm® 120 mg (defined mixture of DMF and calcium (Ca), magnesium (Mg), and zinc (Zn) salts of ethylhydrogenfumarate (EHF, mono-ethyl fumarate (MEF)) will be tested in order to provide better comparative PK data. The comparison of LAS41008 and Fumaderm® PK will be evaluated in an exploratory manner.
The study will be conducted according to a randomised, open-label, four-way complete crossover, single dose design in 32 healthy male and female subjects. Up to 4 discontinued subjects may be replaced in case of early dropouts or a dropout rate greater than 15% (5 or more subjects). Gender balance will also be taken into consideration to ensure that roughly the same number of males and females are randomised. Upon inclusion into the treatment phase, each subject will be randomly allocated to one of four treatment sequences in a 4x4 Williams design. On Day 1 of each treatment period subjects will receive a single oral dose of either LAS41008 120 mg gastro-resistant tablet or Fumaderm® 120 mg gastro-resistant tablet under fasting or fed conditions. The drug administrations will be separated by a wash-out-phase of 7 ± 3 days. Blood sampling for PK will be performed until 24 hours after each study drug administration.
The Informed Consent Form (ICF) will be signed before any study activity, including the withdrawal of any concomitant medication (at least 2 weeks before this screening visit) if required for study participation. The Screening Visit will take place within 28 days before randomisation and after signing of the ICF to check subjects' eligibility. In each period, subjects will be admitted to the study centre from the morning of Day -1 until discharge in the morning of Day 2 (after collection of last blood sampling for PK).
The duration of study participation for each subject from Visit 1 (Screening) to the Follow-up Visit 7 ± 3 days after the last study drug administration is estimated to be approximately 7 to 10 weeks considering study visits time-window allowance.
Two previous Phase 1 studies allowed exploring the PK of LAS41008 30 mg and 120 mg separately after multiple dosing. In the current study, an improved bioanalytical method will allow the detection of lower MMF concentrations, and thus the same gastro-resistant tablet formulation (LAS41008) as used in the previous Phase 1 study will be investigated, but on a larger population and after single oral dose administration. Only the higher LAS41008 dose (120 mg) will be tested, as this is the formulation to be most frequently used during a standard treatment course for psoriasis with LAS41008. Similarly, single oral doses of Fumaderm® 120 mg (defined mixture of DMF and calcium (Ca), magnesium (Mg), and zinc (Zn) salts of ethylhydrogenfumarate (EHF, mono-ethyl fumarate (MEF)) will be tested in order to provide better comparative PK data. The comparison of LAS41008 and Fumaderm® PK will be evaluated in an exploratory manner.
The study will be conducted according to a randomised, open-label, four-way complete crossover, single dose design in 32 healthy male and female subjects. Up to 4 discontinued subjects may be replaced in case of early dropouts or a dropout rate greater than 15% (5 or more subjects). Gender balance will also be taken into consideration to ensure that roughly the same number of males and females are randomised. Upon inclusion into the treatment phase, each subject will be randomly allocated to one of four treatment sequences in a 4x4 Williams design. On Day 1 of each treatment period subjects will receive a single oral dose of either LAS41008 120 mg gastro-resistant tablet or Fumaderm® 120 mg gastro-resistant tablet under fasting or fed conditions. The drug administrations will be separated by a wash-out-phase of 7 ± 3 days. Blood sampling for PK will be performed until 24 hours after each study drug administration.
The Informed Consent Form (ICF) will be signed before any study activity, including the withdrawal of any concomitant medication (at least 2 weeks before this screening visit) if required for study participation. The Screening Visit will take place within 28 days before randomisation and after signing of the ICF to check subjects' eligibility. In each period, subjects will be admitted to the study centre from the morning of Day -1 until discharge in the morning of Day 2 (after collection of last blood sampling for PK).
The duration of study participation for each subject from Visit 1 (Screening) to the Follow-up Visit 7 ± 3 days after the last study drug administration is estimated to be approximately 7 to 10 weeks considering study visits time-window allowance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: