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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-16

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 (Treatment Sequence AB)

Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted

Group Type ACTIVE_COMPARATOR

Cohort 1: Lubiprostone Capsule, Fasted

Intervention Type DRUG

Lubiprostone soft gelatin capsule administered under fasted conditions

Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Intervention Type DRUG

Lubiprostone sprinkle formulation administered under fasted conditions

Cohort 1 (Treatment Sequence BA)

Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted

Group Type EXPERIMENTAL

Cohort 1: Lubiprostone Capsule, Fasted

Intervention Type DRUG

Lubiprostone soft gelatin capsule administered under fasted conditions

Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Intervention Type DRUG

Lubiprostone sprinkle formulation administered under fasted conditions

Cohort 2 (Treatment Sequence CD)

Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted

Group Type EXPERIMENTAL

Cohort 2: Lubiprostone Sprinkle Formulation, Fed

Intervention Type DRUG

Lubiprostone sprinkle formulation administered under fed conditions

Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Intervention Type DRUG

Lubiprostone sprinkle formulation administered under fasted conditions

Cohort 2 (Treatment Sequence DC)

Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed

Group Type EXPERIMENTAL

Cohort 2: Lubiprostone Sprinkle Formulation, Fed

Intervention Type DRUG

Lubiprostone sprinkle formulation administered under fed conditions

Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Intervention Type DRUG

Lubiprostone sprinkle formulation administered under fasted conditions

Interventions

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Cohort 1: Lubiprostone Capsule, Fasted

Lubiprostone soft gelatin capsule administered under fasted conditions

Intervention Type DRUG

Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Lubiprostone sprinkle formulation administered under fasted conditions

Intervention Type DRUG

Cohort 2: Lubiprostone Sprinkle Formulation, Fed

Lubiprostone sprinkle formulation administered under fed conditions

Intervention Type DRUG

Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Lubiprostone sprinkle formulation administered under fasted conditions

Intervention Type DRUG

Other Intervention Names

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AMITIZA® Treatment A Lubiprostone microbeads Treatment B Lubiprostone microbeads Treatment C Lubiprostone microbeads Treatment D

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes