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

Sucampo

Status and phase: Completed; Phase 3

Conditions: Healthy Volunteers

Treatments: Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted; Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed; Drug: Cohort 1: Lubiprostone Capsule, Fasted; Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT03010631

SCMP-0211-304

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

Cohort 1 (Treatment Sequence AB)

Active Comparator group

Description:

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

Treatment:

Drug: Cohort 1: Lubiprostone Capsule, Fasted

Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Cohort 1 (Treatment Sequence BA)

Experimental group

Description:

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

Treatment:

Drug: Cohort 1: Lubiprostone Capsule, Fasted

Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Cohort 2 (Treatment Sequence CD)

Experimental group

Description:

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

Treatment:

Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed

Cohort 2 (Treatment Sequence DC)

Experimental group

Description:

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

Treatment:

Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed