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

NCT03010631 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SCMP-0211-304
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

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

  From the first dose of study drug up to 28 days

Study Arms (4)

Cohort 1 (Treatment Sequence AB)

ACTIVE COMPARATOR

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

Drug: Cohort 1: Lubiprostone Capsule, Fasted; Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Cohort 1 (Treatment Sequence BA)

EXPERIMENTAL

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

Drug: Cohort 1: Lubiprostone Capsule, Fasted; Drug: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted

Cohort 2 (Treatment Sequence CD)

EXPERIMENTAL

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

Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed; Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Cohort 2 (Treatment Sequence DC)

EXPERIMENTAL

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

Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed; Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted

Interventions

Cohort 1: Lubiprostone Capsule, Fasted DRUG

Lubiprostone soft gelatin capsule administered under fasted conditions

Also known as: AMITIZA®, Treatment A

Cohort 1 (Treatment Sequence AB); Cohort 1 (Treatment Sequence BA)

Cohort 1: Lubiprostone Sprinkle Formulation, Fasted DRUG

Lubiprostone sprinkle formulation administered under fasted conditions

Also known as: Lubiprostone microbeads, Treatment B

Cohort 1 (Treatment Sequence AB); Cohort 1 (Treatment Sequence BA)

Cohort 2: Lubiprostone Sprinkle Formulation, Fed DRUG

Lubiprostone sprinkle formulation administered under fed conditions

Also known as: Lubiprostone microbeads, Treatment C

Cohort 2 (Treatment Sequence CD); Cohort 2 (Treatment Sequence DC)

Cohort 2: Lubiprostone Sprinkle Formulation, Fasted DRUG

Lubiprostone sprinkle formulation administered under fasted conditions

Also known as: Lubiprostone microbeads, Treatment D

Cohort 2 (Treatment Sequence CD); Cohort 2 (Treatment Sequence DC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sucampo Pharma Americas, LLC: lead
• Takeda: collaborator

Study Sites (1)

ICON

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• Adams A, Barish C, Chen A, Dennis P, Krause R, Lichtlen P, Losch-Beridon T, Mareya S, Schneider J. Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation. Adv Ther. 2021 Jun;38(6):2936-2952. doi: 10.1007/s12325-021-01707-9. Epub 2021 Apr 8.

  PMID: 33834354 DERIVED

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Limitations and Caveats

Because AUC0-∞ could only be determined in a limited number of participants, AUC0-t was used for primary comparisons.

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Global Clinical Leader

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 5, 2017
• Study Start: November 16, 2016
• Primary Completion: December 23, 2016
• Study Completion: May 1, 2017
• Last Updated: March 9, 2020
• Results First Posted: March 9, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)