Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca®

NCT01822028 | Completed Phase 1

• 1 other identifier: AC-056-102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

diarrhea

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to end of study (day 74)

Secondary Outcomes (1)

• GASTROINTESTINAL TOLERABILITY ENDPOINTS

  baseline to end of study (day 74)

Other Outcomes (2)

• PHARMACOKINETIC ENDPOINTS

  day 16 and day 44

• GENERAL TOLERABILITY/SAFETY ENDPOINTS, OTHER THAN GASTRO-INTESTINAL EVENTS

  baseline to end of study (day 74)

Study Arms (2)

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.

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.

Drug: Treatment A; Drug: Treatment B

Interventions

Treatment A DRUG

Florastor® placebo. Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day).

Also known as: Florastor® placebo., Zavesca® capsules.

Treatment A; Treatment B

Treatment B DRUG

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).

Also known as: Florastor® capsules., Zavesca® capsules.

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (1)

BioPharma Services Inc.

Toronto, Ontario, M9L 3A2, Canada

Location

MeSH Terms

Conditions

Diarrhea

Interventions

miglustat

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad McQueen, PharmD

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: April 2, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

CA (1)