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

Study Overview
=================
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.

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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Cohort 1: Lubiprostone Capsule, Fasted
* Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted
* Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed
* Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1 (Treatment Sequence AB)<br>Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted | Drug: Cohort 1: Lubiprostone Capsule, Fasted<br>* Lubiprostone soft gelatin capsule administered under fasted conditions<br>* Other names: Treatment A;Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted<br>* Lubiprostone sprinkle formulation administered under fasted conditions<br>* Other names: Treatment B;|
| Experimental: Cohort 1 (Treatment Sequence BA)<br>Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted | Drug: Cohort 1: Lubiprostone Capsule, Fasted<br>* Lubiprostone soft gelatin capsule administered under fasted conditions<br>* Other names: Treatment A;Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted<br>* Lubiprostone sprinkle formulation administered under fasted conditions<br>* Other names: Treatment B;|
| Experimental: Cohort 2 (Treatment Sequence CD)<br>Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted | Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed<br>* Lubiprostone sprinkle formulation administered under fed conditions<br>* Other names: Treatment C;Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted<br>* Lubiprostone sprinkle formulation administered under fasted conditions<br>* Other names: Treatment D;|
| Experimental: Cohort 2 (Treatment Sequence DC)<br>Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed | Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed<br>* Lubiprostone sprinkle formulation administered under fed conditions<br>* Other names: Treatment C;Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted<br>* Lubiprostone sprinkle formulation administered under fasted conditions<br>* Other names: Treatment D;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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