Trial · NCT02044419
A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled
NCT02044419, Phase 1, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2018-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled. Trials, record NCT02044419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02044419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled
- NCT number
- NCT02044419
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Healthy
- Interventions
- lomitapide
- First posted
- 2014-01-24
- Last updated
- 2018-02-13
- Results first posted
- 2018-02-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC0-t | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites (M1\& M3). |
| Primary | Cmax | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Maximum observed concentration of lomitapide and its metabolites (M1\& M3). |
| Primary | Tmax | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Time to reach maximum plasma concentration of lomitapide and its metabolites (M1\& M3). |
| Primary | t1/2 | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Terminal elimination half-life of lomitapide and its metabolites (M1\& M3). |
| Primary | AUC0-∞ | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Area under the plasma concentration vs time curve from zero to infinity of lomitapide and its metabolites (M1\& M3). |
| Primary | λz | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | 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). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUC0-t | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | ng*h/mL | MEAN |
| PRIMARY | Cmax | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | ng/mL | MEAN |
| PRIMARY | Tmax | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | hours | MEDIAN |
| PRIMARY | t1/2 | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | h | MEAN |
| PRIMARY | AUC0-∞ | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | ng*h/mL | MEAN |
| PRIMARY | λz | predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose | Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data | 1/h | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| AUC0-t | Lomitapide Sprinkled in Applesauce (Treatment A) | Lomitapide | 38.3 | Standard Deviation 15.2 | ng*h/mL |
| AUC0-t | Lomitapide Sprinkled in Mashed Banana (Treatment B) | Lomitapide | 40.2 | Standard Deviation 13.4 | ng*h/mL |
| AUC0-t | Intact Capsule of 20 mg Lomitapide (Treatment C) | Lomitapide | 43.6 | Standard Deviation 17.7 | ng*h/mL |
| AUC0-t | Lomitapide Sprinkled in Applesauce (Treatment A) | M1 | 70.4 | Standard Deviation 20.2 | ng*h/mL |
| AUC0-t | Lomitapide Sprinkled in Mashed Banana (Treatment B) | M1 | 72.9 | Standard Deviation 23.1 | ng*h/mL |
| AUC0-t | Intact Capsule of 20 mg Lomitapide (Treatment C) | M1 | 75.2 | Standard Deviation 22.8 | ng*h/mL |
| AUC0-t | Lomitapide Sprinkled in Applesauce (Treatment A) | M3 | 443 | Standard Deviation 308 | ng*h/mL |
| AUC0-t | Lomitapide Sprinkled in Mashed Banana (Treatment B) | M3 | 450 | Standard Deviation 292 | ng*h/mL |
| AUC0-t | Intact Capsule of 20 mg Lomitapide (Treatment C) | M3 | 460 | Standard Deviation 325 | ng*h/mL |
| Cmax | Lomitapide Sprinkled in Applesauce (Treatment A) | Lomitapide | 0.986 | Standard Deviation 0.536 | ng/mL |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Applesauce, Mashed Banana, Intact Capsule (ABC) | 11 | |
| First Intervention | STARTED | Mashed Banana, Intact Capsule, Applesauce (BCA) | 10 | |
| First Intervention | STARTED | Intact Capsule, Applesauce, Mashed Banana (CAB) | 11 | |
| First Intervention | COMPLETED | Applesauce, Mashed Banana, Intact Capsule (ABC) | 11 | |
| First Intervention | COMPLETED | Mashed Banana, Intact Capsule, Applesauce (BCA) | 9 | |
| First Intervention | COMPLETED | Intact Capsule, Applesauce, Mashed Banana (CAB) | 10 | |
| First Intervention | NOT COMPLETED | Applesauce, Mashed Banana, Intact Capsule (ABC) | 0 | |
| First Intervention | NOT COMPLETED | Mashed Banana, Intact Capsule, Applesauce (BCA) | 1 | |
| First Intervention | NOT COMPLETED | Intact Capsule, Applesauce, Mashed Banana (CAB) | 1 | |
| Second Intervention | STARTED | Applesauce, Mashed Banana, Intact Capsule (ABC) | 11 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Lomitapide Sprinkled in Applesauce (Treatment A) | 0 | 30 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Lomitapide Sprinkled in Mashed Banana (Treatment B) | 0 | 31 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Intact Capsule of 20 mg Lomitapide (Treatment C) | 1 | 31 | 1 |
| other | Headache | Nervous system disorders | Lomitapide Sprinkled in Applesauce (Treatment A) | 1 | 30 | 1 |
| other | Headache | Nervous system disorders | Lomitapide Sprinkled in Mashed Banana (Treatment B) | 0 | 31 | 0 |
| other | Headache | Nervous system disorders | Intact Capsule of 20 mg Lomitapide (Treatment C) | 0 | 31 | 0 |
| other | Polyuria | Renal and urinary disorders | Lomitapide Sprinkled in Applesauce (Treatment A) | 1 | 30 | 1 |
| other | Polyuria | Renal and urinary disorders | Lomitapide Sprinkled in Mashed Banana (Treatment B) | 0 | 31 | 0 |
| other | Polyuria | Renal and urinary disorders | Intact Capsule of 20 mg Lomitapide (Treatment C) | 0 | 31 | 0 |
| other | Presyncope | Vascular disorders | Lomitapide Sprinkled in Applesauce (Treatment A) | 1 | 30 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lomitapide Sprinkled in Applesauce (Treatment A) | 0 | 30 |
| Total, all-cause mortality | Lomitapide Sprinkled in Mashed Banana (Treatment B) | 0 | 31 |
| Total, all-cause mortality | Intact Capsule of 20 mg Lomitapide (Treatment C) | 0 | 31 |
| Total, other adverse events | Lomitapide Sprinkled in Applesauce (Treatment A) | 5 | 30 |
| Total, other adverse events | Lomitapide Sprinkled in Mashed Banana (Treatment B) | 6 | 31 |
| Total, other adverse events | Intact Capsule of 20 mg Lomitapide (Treatment C) | 6 | 31 |
| Total, serious adverse events | Lomitapide Sprinkled in Applesauce (Treatment A) | 0 | 30 |
| Total, serious adverse events | Lomitapide Sprinkled in Mashed Banana (Treatment B) | 0 | 31 |
| Total, serious adverse events | Intact Capsule of 20 mg Lomitapide (Treatment C) | 0 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02044419
GET https://conductscience.org/api/trials/v1/NCT02044419/results?page=2