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

Healthy Volunteers Clinical Trial

Official title:

Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010631
• Other study ID #: SCMP-0211-304
• Status: Completed
• Phase: Phase 3
• Start date: November 16, 2016
• Est. completion date: May 2017

Study information

• Verified date: March 2018
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2017
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Cohort 1: Lubiprostone Capsule, Fasted
Lubiprostone soft gelatin capsule administered under fasted conditions
• Cohort 1: Lubiprostone Sprinkle Formulation, Fasted
Lubiprostone sprinkle formulation administered under fasted conditions
• Cohort 2: Lubiprostone Sprinkle Formulation, Fed
Lubiprostone sprinkle formulation administered under fed conditions
• Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
Lubiprostone sprinkle formulation administered under fasted conditions

Locations

Country	Name	City	State
United States	ICON	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.	From the first dose of study drug up to 28 days
Primary	Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite		1 day
Primary	Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite		1 day
Secondary	Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition		1 day
Secondary	Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions		1 day