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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Treatment Sequence AB) | Active Comparator | Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted |
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| Cohort 1 (Treatment Sequence BA) | Experimental | Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted |
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| Cohort 2 (Treatment Sequence CD) | Experimental | Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted |
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| Cohort 2 (Treatment Sequence DC) | Experimental | Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1: Lubiprostone Capsule, Fasted | Drug | Lubiprostone soft gelatin capsule administered under fasted conditions |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33834354 | Derived | 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. |
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Treatment periods for Cohorts 1 and 2 did not have the same participants.
Participants in each cohort were randomized to sequence.
In each sequence the first treatment was given for 14 days, there was a 7-day washout period, and then the second treatment was given for 14 days.
All participants were recruited in the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Treatment A Then Treatment B | Participants in Cohort 1 who received Treatment A: Lubiprostone Capsule, Fasted for 14 days, followed (after a 7-day washout) by Treatment B: Sprinkle Formulation, Fasted for 14 days |
| FG001 | Cohort 1: Treatment B Then Treatment A |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Cohort 1 |
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| Cohort 1: Lubiprostone Sprinkle Formulation, Fasted | Drug | Lubiprostone sprinkle formulation administered under fasted conditions |
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| Cohort 2: Lubiprostone Sprinkle Formulation, Fed | Drug | Lubiprostone sprinkle formulation administered under fed conditions |
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| Cohort 2: Lubiprostone Sprinkle Formulation, Fasted | Drug | Lubiprostone sprinkle formulation administered under fasted conditions |
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| From the first dose of study drug up to 28 days |
Participants in Cohort 1 who received Treatment B: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment A: Lubiprostone Capsule, Fasted for 14 days |
| FG002 | Cohort 2: Treatment C Then Treatment D | Participants in Cohort 2 who received Treatment C: Sprinkle, Fed for 14 days, followed (after a 7-day washout) by Treatment D: Sprinkle Formulation, Fasted for 14 days |
| FG003 | Cohort 2: Treatment D Then Treatment C | Participants in Cohort 2 who received Treatment D: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment C: Sprinkle, Fed for 14 days |
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| COMPLETED |
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| NOT COMPLETED |
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| Cohort 2 |
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Safety Population, defined as all randomized participants who took at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Treatment A Then Treatment B | Participants in Cohort 1 who received Treatment A: Lubiprostone Capsule, Fasted for 14 days, followed (after a 7-day washout) by Treatment B: Sprinkle Formulation, Fasted for 14 days |
| BG001 | Cohort 1: Treatment B Then Treatment A | Participants in Cohort 1 who received Treatment B: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment A: Lubiprostone Capsule, Fasted for 14 days |
| BG002 | Cohort 2: Treatment C Then Treatment D | Participants in Cohort 2 who received Treatment C: Sprinkle, Fed for 14 days, followed (after a 7-day washout) by Treatment D: Sprinkle Formulation, Fasted for 14 days |
| BG003 | Cohort 2: Treatment D Then Treatment C | Participants in Cohort 2 who received Treatment D: Sprinkle Formulation, Fasted for 14 days, followed (after a 7-day washout) by Treatment C: Sprinkle, Fed for 14 days |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite | PK population, defined as those with plasma concentration of lubiprostone or M3 sufficient to calculate at least 1 PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | 1 day |
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| Primary | Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite | Evaluable PK Population included all participants in the PK Population who had sufficient plasma drug concentration data of either lubiprostone or M3 to calculate at least 1 evaluable PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 1 day |
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| Secondary | Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition | PK Evaluable Population. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | h*pg/mL | 1 day |
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| Secondary | Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions | PK Evaluable Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 1 day |
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| Other Pre-specified | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety Population. | Posted | Count of Participants | Participants | From the first dose of study drug up to 28 days |
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From first dose of study drug up to 28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | All participants who received lubiprostone 2x24 μg capsule once orally. | 0 | 31 | 0 | 31 | 13 | 31 |
| EG001 | Treatment B | All participants who received lubiprostone 2x24 μg sprinkle formulation once orally. | 0 | 35 | 0 | 35 | 23 | 35 |
| EG002 | Treatment C | All participants who received lubiprostone 2x24 μg sprinkle formulation once orally under fed conditions. | 0 | 14 | 0 | 14 | 6 | 14 |
| EG003 | Treatment D | All participants who received lubiprostone 2x24 μg sprinkle formulation once orally under fasted conditions. | 0 | 14 | 0 | 14 | 6 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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Because AUC0-∞ could only be determined in a limited number of participants, AUC0-t was used for primary comparisons.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Cohort 2 participants who received Treatment C
| OG003 | Treatment D: Sprinkle Formulation, Fasted | Cohort 2 participants who received Treatment D |
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