Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the relative bioavailability of lomitapide when administered by sprinkling the contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral intact capsule dose of 20 mg lomitapide in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lomitapide sprinkled in applesauce | Experimental | Contents of single 20 mg capsule of lomitapide sprinkled in applesauce |
|
| lomitapide sprinkled in mashed banana | Experimental | Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana |
|
| lomitapide (intact) | Experimental | Intact capsule of 20 mg lomitapide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lomitapide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites (M1& M3). | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Cmax | Maximum observed concentration of lomitapide and its metabolites (M1& M3). | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Tmax | Time to reach maximum plasma concentration of lomitapide and its metabolites (M1& M3). | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
| t1/2 | Terminal elimination half-life of lomitapide and its metabolites (M1& M3). | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
| AUC0-∞ | Area under the plasma concentration vs time curve from zero to infinity of lomitapide and its metabolites (M1& M3). | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
| λz | Elimination rate constant estimated from individual linear regression of the terminal part of the log concentration vs time curve of lomitapide and its metabolites (M1& M3). | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Sumeray, MD | Aegerion Pharmaceuticals, Inc. | Study Chair |
| Ulrike Lorch, MD | Richmond Phamacology, LTD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd | Croydon | Surrey | CR7 7YE | United Kingdom |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Applesauce, Mashed Banana, Intact Capsule (ABC) | First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide |
| FG001 | Mashed Banana, Intact Capsule, Applesauce (BCA) | First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Second Intervention: Intact capsule of 20 mg lomitapide Third Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce |
| FG002 | Intact Capsule, Applesauce, Mashed Banana (CAB) | First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Third Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Applesauce, Mashed Banana, Intact Capsule (ABC) | Contents of single 20 mg capsule of lomitapide sprinkled in applesauce, mashed banana Capsule taken intact lomitapide |
| BG001 | Mashed Banana, Intact Capsule, Applesauce (BCA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-t | Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites (M1& M3). | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | Posted | Mean | Standard Deviation | ng*h/mL | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lomitapide Sprinkled in Applesauce (Treatment A) | Contents of single 20 mg capsule of lomitapide sprinkled in applesauce |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment | Constipation Vomitting |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Long, MD - VP Clinical | Aegerion Pharmaceuticals, Inc. | 857-242-5142 | alison.long@aegerion.com |
Not provided
| ID | Term |
|---|---|
| C473731 | BMS201038 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana
Capsule taken intact
lomitapide
| BG002 | Intact Capsule, Applesauce, Mashed Banana (CAB) | Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana Capsule taken intact lomitapide |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Intact Capsule of 20 mg Lomitapide (Treatment C) | Intact capsule of 20 mg lomitapide |
|
|
| Primary | Cmax | Maximum observed concentration of lomitapide and its metabolites (M1& M3). | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | Posted | Mean | Standard Deviation | ng/mL | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
|
|
|
| Primary | Tmax | Time to reach maximum plasma concentration of lomitapide and its metabolites (M1& M3). | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | Posted | Median | Full Range | hours | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
|
|
|
| Primary | t1/2 | Terminal elimination half-life of lomitapide and its metabolites (M1& M3). | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | Posted | Mean | Standard Deviation | h | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
|
|
|
| Primary | AUC0-∞ | Area under the plasma concentration vs time curve from zero to infinity of lomitapide and its metabolites (M1& M3). | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | Posted | Mean | Standard Deviation | ng*h/mL | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
|
|
|
| Primary | λz | Elimination rate constant estimated from individual linear regression of the terminal part of the log concentration vs time curve of lomitapide and its metabolites (M1& M3). | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | Posted | Mean | Standard Deviation | 1/h | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 5 |
| 30 |
| EG001 | Lomitapide Sprinkled in Mashed Banana (Treatment B) | Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana | 0 | 31 | 0 | 31 | 6 | 31 |
| EG002 | Intact Capsule of 20 mg Lomitapide (Treatment C) | Intact capsule of 20 mg lomitapide | 0 | 31 | 0 | 31 | 6 | 31 |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Presyncope | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
Described in contract.
|
| M3 |
|
|
| M3 |
|
|
| M3 |
|
|
| M3 |
|
|
| M3 |
|