Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers

Phase 3

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT03010631
• Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary

A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.

Detailed Description

To compare the pharmacokinetics of the sprinkle formulation of lubiprostone, as compared to lubiprostone capsules and to determine the effect of food on the bioavailability and plasma pharmacokinetics of lubiprostone sprinkle.

Study Timeline

• Study Start: 2016-11-16
• Study First Submitted: 2016-12-20
• Primary Completion: 2016-12-23
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Study Completion: 2017-05
• Status Verified: 2018-03
• Disposition First Submitted: 2018-03-22
• Disposition First Submitted QC: 2018-03-26
• Disposition First Posted: 2018-03-29
• Results First Submitted: 2019-12-06
• Results First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Results First Posted: 2020-03-09
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Is male or female, between 18 and 55 years of age, inclusive.
• Has a 12-lead electrocardiogram (ECG) within normal limits and is in good health based upon review of medical history, physical examination results, vital signs (within normal range), and normal laboratory profile for both blood and urine.

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Exclusion Criteria

• Has an active or recent history of alcoholism or drug addiction (within 1 year prior)
• Is a smoker or has a recent history of smoking (within 6 months)
• Routinely consumes food known to alter drug metabolism (i.e., grapefruit juice, coffee, tea, cola, chocolate, cocoa, or other caffeine or methyl-xanthine containing foods or beverages) and/or cannot refrain from these items
• Has donated blood within 3 months
• Has a medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite	1 day
Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite	1 day

Secondary Outcome Measures

Name	Time	Method
Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions	1 day
Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition	1 day

Trial Locations

Locations (1)

ICON; 🇺🇸 San Antonio, Texas, United States