Minneapolis Clinical Trials
Food Effect Study
Purpose: to evaluate the safety and tolerability of an investigational medication for cystic fibrosis.
9 nights
1 visits
Participate in a clinical study of a potential new treatment for cystic fibrosis. This is Part C of the study.
Reimbursement for study participation will be provided for time of up to $3,714.
This study requires one inpatient stay of 9 nights / 10 days and 1 follow up phone call.
Call 612-315-6490 to discuss your eligibility today!
Part C will involve a fasted and fed dosing study where you will participate in 3 study treatment segments, taking the study drug (SION-638) three different times. There will be a 72-hour period between each treatment segment, this is called a washout.
- Study Treatment I is a single oral dose as a suspension after 10 hours of fasting
- Study Treatment II is a single oral dose as tablet(s) after10 hours of fasting.
- Study Treatment III is a single oral dose as tablet(s) given 30 minutes following a standardized high fat breakfast.
Eligibility
Age: 18-55
BMI: 18-32kg/m2
Medications: No current over the counter or prescribed medications
Smoking Status: Non-smokers
Compensation: Up to $3,714
Standard High Fat Meal: Two eggs fried in butter, Two strips of bacon, Two slices of toast with butter, Four ounces of hash brown potatoes, eight ounces of whole milk