Healthy VolunteersPhase 3NCT03010631
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
A Phase 3 study testing Cohort 1: Lubiprostone Capsule, Fasted, Cohort 1: Lubiprostone Sprinkle Formulation, Fasted and Cohort 2: Lubiprostone Sprinkle Formulation, Fed in people with Healthy Volunteers, run by Sucampo Pharma Americas, LLC at 1 site in United States.
Trial summary
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cohort 1: Lubiprostone Capsule, Fasted, Cohort 1: Lubiprostone Sprinkle Formulation, Fasted and Cohort 2: Lubiprostone Sprinkle Formulation, Fed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2016to May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Cohort 1: Lubiprostone Capsule, Fasted, Cohort 1: Lubiprostone Sprinkle Formulation, Fasted, Cohort 2: Lubiprostone Sprinkle Formulation, Fed, Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1: Lubiprostone Capsule, FastedDrug
Also called AMITIZA®, Treatment A
Lubiprostone soft gelatin capsule administered under fasted conditions
Cohort 1: Lubiprostone Sprinkle Formulation, FastedDrug
Also called Lubiprostone microbeads, Treatment B
Lubiprostone sprinkle formulation administered under fasted conditions
Cohort 2: Lubiprostone Sprinkle Formulation, FedDrug
Also called Lubiprostone microbeads, Treatment C
Lubiprostone sprinkle formulation administered under fed conditions
Cohort 2: Lubiprostone Sprinkle Formulation, FastedDrug
Also called Lubiprostone microbeads, Treatment D
Lubiprostone sprinkle formulation administered under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Treatment Sequence AB) | Active comparator | Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed; Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite
Measured: 1 day
Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
Measured: 1 day
Secondary outcomes (2)
Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition
Measured: 1 day
Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start16 Nov 2016
- Primary completion23 Dec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010631
- Sponsor's protocol ID
- SCMP-0211-304
- Status last verified
- Mar 2018
- First submitted
- 20 Dec 2016
- Last updated
- 9 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33834354
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics and Food-Effect Bioavailability of a Sprinkle Formulation of Lubiprostone After Oral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03010631
- Acronym / sponsor ID
- SCMP-0211-304
- Conditions
- Healthy Volunteers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 9 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Treatment Sequence AB) | Active comparator | Drug: Cohort 1: Lubiprostone Capsule, Fasted, Drug: Cohort 1: Lubiprostone Sprinkle Formulation, FastedCohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted |
| Cohort 1 (Treatment Sequence BA) | Experimental | Drug: Cohort 1: Lubiprostone Capsule, Fasted, Drug: Cohort 1: Lubiprostone Sprinkle Formulation, FastedCohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted |
| Cohort 2 (Treatment Sequence CD) | Experimental | Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed, Drug: Cohort 2: Lubiprostone Sprinkle Formulation, FastedCohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted |
| Cohort 2 (Treatment Sequence DC) | Experimental | Drug: Cohort 2: Lubiprostone Sprinkle Formulation, Fed, Drug: Cohort 2: Lubiprostone Sprinkle Formulation, FastedCohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1: Lubiprostone Capsule, FastedAlso: AMITIZA®, Treatment ALubiprostone soft gelatin capsule administered under fasted conditions | Drug | Cohort 1 (Treatment Sequence AB), Cohort 1 (Treatment Sequence BA) |
| Cohort 1: Lubiprostone Sprinkle Formulation, FastedAlso: Lubiprostone microbeads, Treatment BLubiprostone sprinkle formulation administered under fasted conditions | Drug | Cohort 1 (Treatment Sequence AB), Cohort 1 (Treatment Sequence BA) |
| Cohort 2: Lubiprostone Sprinkle Formulation, FedAlso: Lubiprostone microbeads, Treatment CLubiprostone sprinkle formulation administered under fed conditions | Drug | Cohort 2 (Treatment Sequence CD), Cohort 2 (Treatment Sequence DC) |
| Cohort 2: Lubiprostone Sprinkle Formulation, FastedAlso: Lubiprostone microbeads, Treatment DLubiprostone sprinkle formulation administered under fasted conditions | Drug | Cohort 2 (Treatment Sequence CD), Cohort 2 (Treatment Sequence DC) |
Primary outcome
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
Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite
Time frame: 1 day
2 secondary outcomes
Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition
Time frame: 1 day
Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33834354Adams 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Mallinckrodt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cohort 1: Lubiprostone Capsule, Fasted, Cohort 1: Lubiprostone Sprinkle Formulation, Fasted and Cohort 2: Lubiprostone Sprinkle Formulation, Fed in people with Healthy Volunteers, run by Sucampo Pharma Americas, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.