DiarrheaPhase 1NCT01822028
Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca®
A Phase 1 study testing Treatment A and Treatment B in people with Diarrhea, run by Actelion at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Treatment A and Treatment B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent prior to any study-mandated procedure
- Healthy male and female subjects aged between 18 and 55 years (inclusive) at Screening
- Women must have a negative serum pregnancy test at Screening and negative urine pregnancy test at the first day of each treatment period and must use a reliable method of contraception from Screening during the entire study and up to 30 days after the last dose. Male subjects must agree to use reliable contraception throughout the study and for 4 months after study drug discontinuation
- Reliable methods of contraception for all subjects include the following:
- Barrier type devices (e.g., male and female condom, diaphragm and contraceptive sponges) used ONLY in combination with a spermicide
- Intrauterine devices
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- Oral contraceptive agent
- Depo-Provera (medroxyprogesterone acetate)
- Levonorgestrel implants
- Abstinence, the rhythm method, and contraception by the partner alone are NOT reliable methods of contraception
- A BMI of 18.5 to 30 kg/m2 (inclusive) at Screening
- No clinically significant findings on the physical examination, laboratory assessment, electrocardiogram (ECG), and vital signs at Screening
Who cannot join
- Ingestion of any medication within 7 days prior to study enrollment (Day 1) except contraceptives
- Use of anti-diarrheal medications within 30 days prior to study enrollment (e.g., loperamide)
- Use of oral probiotic supplements or S. boulardii within 30 days prior to study enrollment
- Use of oral antifungals or antibiotics within 8 weeks prior to study enrollment
- History of yeast allergy
- Current alcohol or drug dependence
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- Renal function impairment, (i.e., creatinine clearance [C Cr]<70 mL/min/1.73m2 as per Cockroft-Gault)
- History of GI distress including diarrhea (more than 2 loose stools per day, for 5 or more days) within 30 days prior to study enrollment
- History of irritable bowel syndrome, inflammatory bowel disease, or other disease resulting in frequent or severe diarrhea
- Lactose intolerance
- Subjects on any specialized diet, including low carbohydrate diets Lactating, pregnant women or women who plan to become pregnant during the course of the study
- History of any neurological disease/symptom, e.g., convulsion
- Loss of 500 mL or more of blood within 3 months prior to Screening
- Positive results to HIV Ag/Ab, HBsAg or anti-HCV tests
- Positive results from the HIV serology at Screening
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening
- Excessive caffeine consumption, defined as >=5 cups of coffee a day or 800mg/day at Screening
- Smoking within 3 months prior to Screening and inability to refrain from smoking during the course of the study
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- Legal incapacity or limited legal capacity at Screening
- Unplanned weight loss defined as >5% within the past month or >=10% during the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 (b.i.d.) from Day 1 to Day 16 of the treatment period, and miglustat capsules 100 mg t.i.d. from Day 3 to Day 16.
- Treatment B: S. boulardii 500 mg b.i.d. from Day 1 to Day 16 of the treatment period, and miglustat capsules 100 mg t.i.d. 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 SAEs/AEs 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.
- Conditions
- Diarrhea
- Being tested
- Treatment A, Treatment B
- Keywords
- diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Also called Florastor® placebo., Zavesca® capsules.
Florastor® placebo. Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day).
Treatment BDrug
Also called Florastor® capsules., Zavesca® capsules.
Florastor® capsules dosed at 1000 mg daily (two 250 mg capsules two times per day).
Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day).
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Placebo comparator | Treatment A: Florastor® 500 mg twice per day from Day 1 to Day 16 of the treatment period, and Zavesca® 100 mg three times per day from Day 3 to Day 16.
For Period 2, subjects will receive the alternate dosing regimen. Receives: Drug: Treatment A; Drug: Treatment B |
| Treatment B | Experimental | Treatment B: Florastor® 500 mg twice per day from Day 1 to Day 16 of the treatment period, and Zavesca® 100 mg three times per day from Day 3 to Day 16.
For Period 2, subjects will receive the alternate dosing regimen. Receives: Drug: Treatment A; Drug: Treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
GASTROINTESTINAL TOLERABILITY ENDPOINTS
Total number of days of diarrhea defined as 3 or more loose stools within a 24-hour period (WHO criteria) that meet the criteria of Bristol Stool Score 6-7.
Measured: baseline to end of study (day 74)
Secondary outcomes (1)
GASTROINTESTINAL TOLERABILITY ENDPOINTS
Number of consecutive days of diarrhea defined as 3 or more loose stools (WHO criteria) within consecutive 24-hour periods that meet the criteria of Bristol Stool Score of 6-7.
Measured: baseline to end of study (day 74)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad McQueen, PharmD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822028
- Sponsor's protocol ID
- AC-056-102
- Status last verified
- Mar 2015
- First submitted
- 6 Mar 2013
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01822028
- Acronym / sponsor ID
- AC-056-102
- Conditions
- Diarrhea
- Keywords
- diarrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (b.i.d.) from Day 1 to Day 16 of the treatment period, and miglustat capsules 100 mg t.i.d. from Day 3 to Day 16.
- Treatment B: S. boulardii 500 mg b.i.d. from Day 1 to Day 16 of the treatment period, and miglustat capsules 100 mg t.i.d. 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 SAEs/AEs 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Placebo comparator | Drug: Treatment A, Drug: Treatment BTreatment A: Florastor® 500 mg twice per day from Day 1 to Day 16 of the treatment period, and Zavesca® 100 mg three times per day from Day 3 to Day 16. For Period 2, subjects will receive the alternate dosing regimen. |
| Treatment B | Experimental | Drug: Treatment A, Drug: Treatment BTreatment B: Florastor® 500 mg twice per day from Day 1 to Day 16 of the treatment period, and Zavesca® 100 mg three times per day from Day 3 to Day 16. For Period 2, subjects will receive the alternate dosing regimen. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Signed informed consent prior to any study-mandated procedure
- Healthy male and female subjects aged between 18 and 55 years (inclusive) at Screening
- Women must have a negative serum pregnancy test at Screening and negative urine pregnancy test at the first day of each treatment period and must use a reliable method of contraception from Screening during the entire study and up to 30 days after the last dose. Male subjects must agree to use reliable contraception throughout the study and for 4 months after study drug discontinuation
- Reliable methods of contraception for all subjects include the following:
- Barrier type devices (e.g., male and female condom, diaphragm and contraceptive sponges) used ONLY in combination with a spermicide
Key exclusion criteria (21 listed)
- Ingestion of any medication within 7 days prior to study enrollment (Day 1) except contraceptives
- Use of anti-diarrheal medications within 30 days prior to study enrollment (e.g., loperamide)
- Use of oral probiotic supplements or S. boulardii within 30 days prior to study enrollment
- Use of oral antifungals or antibiotics within 8 weeks prior to study enrollment
- History of yeast allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment AAlso: Florastor® placebo., Zavesca® capsules.Florastor® placebo. Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day). | Drug | Treatment A, Treatment B |
| Treatment BAlso: Florastor® capsules., Zavesca® capsules.Florastor® capsules dosed at 1000 mg daily (two 250 mg capsules two times per day). Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day). | Drug | Treatment A, Treatment B |
Primary outcome
GASTROINTESTINAL TOLERABILITY ENDPOINTS
Time frame: baseline to end of study (day 74)
Total number of days of diarrhea defined as 3 or more loose stools within a 24-hour period (WHO criteria) that meet the criteria of Bristol Stool Score 6-7.
1 secondary outcome
GASTROINTESTINAL TOLERABILITY ENDPOINTS
Time frame: baseline to end of study (day 74)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad McQueen, PharmD study director
Actelion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A and Treatment B in people with Diarrhea, run by Actelion at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GASTROINTESTINAL TOLERABILITY ENDPOINTS (time frame: baseline to end of study (day 74)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.