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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Actelion
• Treatments: 1-Deoxynojirimycin; Miglustat

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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