Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01822028
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2013-03-06
Brief Title:
Two Period Two Treatment Cross-over to Assess the Effect of Florastor on Gastrointestinal Tolerability Safety and PK in Healthy Subjects Receiving Zavesca
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Single-center Double-blind Randomized Placebo-controlled Two Period Two Treatment Cross-over Study to Assess the Effect of Florastor Saccharomyces Boulardii Lyo on Gastrointestinal Tolerability Safety and Pharmacokinetics of Zavesca Miglustat in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Cross-over tolerability study with healthy subjects taking Zavesca in combination with Florastor Forty-two subjects will be randomized to one of two treatment sequences of Zavesca with Florastor and Zavesca with Placebo of Florastor Gastrointestinal tolerability and PK endpoints demographic laboratory and safety testing and AEs and SAEs will be collected throughout the seventy-four day study
Detailed Description:
This is a Phase 1 single-center double-blind randomized placebo-controlled two period two treatment cross-over study with GI tolerability safety and PK assessments A total of 42 healthy subjects will be enrolled At least 30 of female subjects are expected to be enrolled Subjects will participate in 2 treatment periods Treatment Period 1 and Treatment Period 2 separated by a 10- to 14-day washout
Subjects will be randomly allocated to the treatment sequence A-B or B-A
Treatment A Placebo of S boulardii 500 mg twice a day bid from Day 1 to Day 16 of the treatment period and miglustat capsules 100 mg tid from Day 3 to Day 16
Treatment B S boulardii 500 mg bid from Day 1 to Day 16 of the treatment period and miglustat capsules 100 mg tid from Day 3 to Day 16
To minimize possible carry-over effect a 10 to 14-day washout period is added between Treatment Period 1 and Period 2 Steady-state PK evaluations will occur at the end of Period 1 and Period 2 requiring full-day clinic stays by each subject
The planned study duration per subject will be approximately 46 days not inclusive of Screening and serious adverse event SAE follow-up periods However the duration may be up to 53 days if all visit windows are utilized The Screening period may last up to 30 days prior to the first administration of study medication Telephone follow-up will occur within 48-72 hours after last study drug dose in each treatment period to record SAEsAEs and concomitant medications In addition subjects will be followed up 30 days after permanent study drug discontinuation for ongoing AEs and new SAEs via a telephone consult
Subjects will be randomly allocated to the treatment sequence A-B or B-A
Treatment A Placebo of S boulardii 500 mg twice a day bid from Day 1 to Day 16 of the treatment period and miglustat capsules 100 mg tid from Day 3 to Day 16
Treatment B S boulardii 500 mg bid from Day 1 to Day 16 of the treatment period and miglustat capsules 100 mg tid from Day 3 to Day 16
To minimize possible carry-over effect a 10 to 14-day washout period is added between Treatment Period 1 and Period 2 Steady-state PK evaluations will occur at the end of Period 1 and Period 2 requiring full-day clinic stays by each subject
The planned study duration per subject will be approximately 46 days not inclusive of Screening and serious adverse event SAE follow-up periods However the duration may be up to 53 days if all visit windows are utilized The Screening period may last up to 30 days prior to the first administration of study medication Telephone follow-up will occur within 48-72 hours after last study drug dose in each treatment period to record SAEsAEs and concomitant medications In addition subjects will be followed up 30 days after permanent study drug discontinuation for ongoing AEs and new SAEs via a telephone consult
Study Oversight
Has Oversight DMC:
None
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?:
None