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Completed

NCT Number: NCT03010631

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ICON

San Antonio, Texas, 78209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cohort 1: Lubiprostone Capsule, Fasted

Drug

Lubiprostone soft gelatin capsule administered under fasted conditions

Other names: AMITIZA®, Treatment A

Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Drug

Lubiprostone sprinkle formulation administered under fasted conditions

Other names: Lubiprostone microbeads, Treatment B

Cohort 2: Lubiprostone Sprinkle Formulation, Fed

Drug

Lubiprostone sprinkle formulation administered under fed conditions

Other names: Lubiprostone microbeads, Treatment C

Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Drug

Lubiprostone sprinkle formulation administered under fasted conditions

Other names: Lubiprostone microbeads, Treatment D

Primary outcomes

  1. Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite

    Time frame: 1 day

  2. Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite

    Time frame: 1 day

Secondary outcomes

  1. Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition

    Time frame: 1 day

  2. Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions

    Time frame: 1 day

Other outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From the first dose of study drug up to 28 days

    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.

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Takeda

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 5, 2017
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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