Trial · NCT02080455
Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
NCT02080455, Phase 1, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2020-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects. Trials, record NCT02080455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02080455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
- NCT number
- NCT02080455
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
- Interventions
- lomitapide, Atorvastatin
- First posted
- 2014-03-06
- Last updated
- 2020-03-10
- Results first posted
- 2020-03-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 \& M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1) |
| Primary | Tmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 \& M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1) |
| Primary | AUC0-t | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Area under the concentration-time curve from zero to the last quantifiable concentration of lomitapide and its 2 primary metabolites (M1 \& M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1) |
| Primary | AUC0-∞ | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites (M1 \& M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1) |
| Primary | t1/2 | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites (M1 \& M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1) |
| Secondary | Cmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 \& M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2) |
| Secondary | Tmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 \& M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2) |
| Secondary | AUC0-t | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Area under the concentration-time curve from zero to the last quantifiable concentration of lomitapide and its 2 primary metabolites (M1 \& M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2) |
| Secondary | AUC0-∞ | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites (M1 \& M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2) |
| Secondary | t1/2 | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites (M1 \& M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data. | hr | MEDIAN |
| PRIMARY | AUC0-t | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC0-∞ | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data. 2 subjects were removed from formal statistical analysis of PK of M3 (Lomitapide alone) due to missing value of AUC0-∞ for Analyte M3. | ng*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | t1/2 | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 2 subjects were removed from formal statistical analysis of PK of M3 (Lomitapide alone) due to missing value of AUC0-∞ for Analyte M3. | hr | GEOMETRIC_MEAN |
| SECONDARY | Tmax | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3. | hr | MEDIAN |
| SECONDARY | AUC0-t | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-∞ | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 3 subjects were removed from formal statistical analysis due to BLQ values on Day 1, missing value of AUC0-∞ on Day 1, and missing value of AUC0-∞ on Day 15. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | t1/2 | Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing | The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 3 subjects were removed from formal statistical analysis due to BLQ values on Day 1, missing value of AUC0-∞ on Day 1, and missing value of AUC0-∞ on Day 15. | hr | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax | PK of Lomitapide (Lomitapide Alone) | 0.940 | Geometric Coefficient of Variation 34.5 | ng/mL | |
| Cmax | PK of Lomitapide (Coadministered Simultaneously) | 2.00 | Geometric Coefficient of Variation 52.9 | ng/mL | |
| Cmax | PK of M1 (Lomitapide Alone) | 2.24 | Geometric Coefficient of Variation 22.8 | ng/mL | |
| Cmax | PK of M1 (Coadministered Simultaneously) | 2.11 | Geometric Coefficient of Variation 31.9 | ng/mL | |
| Cmax | PK of M3 (Lomitapide Alone) | 32.3 | Geometric Coefficient of Variation 40.6 | ng/mL | |
| Cmax | PK of M3 (Coadministered Simultaneously) | 27.2 | Geometric Coefficient of Variation 62.0 | ng/mL | |
| Tmax | PK of Lomitapide (Lomitapide Alone) | 6.00 | Full Range 3.00 to 10.0 | hr | |
| Tmax | PK of Lomitapide (Coadministered Simultaneously) | 10.0 | Full Range 3.00 to 23.8 | hr | |
| Tmax | PK of M1 (Lomitapide Alone) | 6.02 | Full Range 4.00 to 10.0 | hr | |
| Tmax | PK of M1 (Coadministered Simultaneously) | 10.0 | Full Range 4.00 to 23.8 | hr |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lomitapide & Atorvastatin - Taken Together | 16 | |
| Overall Study | STARTED | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 16 | |
| Overall Study | COMPLETED | Lomitapide & Atorvastatin - Taken Together | 16 | |
| Overall Study | COMPLETED | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 16 | |
| Overall Study | NOT COMPLETED | Lomitapide & Atorvastatin - Taken Together | 0 | |
| Overall Study | NOT COMPLETED | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 0 |
Source ClinicalTrials.gov
Adverse events30
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 | Diarrhoea | Gastrointestinal disorders | Lomitapide & Atorvastatin - Taken Together | 10 | 16 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 2 | 16 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Lomitapide & Atorvastatin - Taken Together | 4 | 16 | 5 |
| other | Abdominal Pain | Gastrointestinal disorders | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 1 | 16 | 1 |
| other | Nausea | Gastrointestinal disorders | Lomitapide & Atorvastatin - Taken Together | 3 | 16 | 3 |
| other | Nausea | Gastrointestinal disorders | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 0 | 16 | 0 |
| other | Constipation | Gastrointestinal disorders | Lomitapide & Atorvastatin - Taken Together | 0 | 16 | 0 |
| other | Constipation | Gastrointestinal disorders | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 1 | 16 | 1 |
| other | Toothache | Gastrointestinal disorders | Lomitapide & Atorvastatin - Taken Together | 1 | 16 | 1 |
| other | Toothache | Gastrointestinal disorders | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 0 | 16 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lomitapide & Atorvastatin - Taken Together | 0 | 16 |
| Total, all-cause mortality | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 0 | 16 |
| Total, other adverse events | Lomitapide & Atorvastatin - Taken Together | 12 | 16 |
| Total, other adverse events | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 5 | 16 |
| Total, serious adverse events | Lomitapide & Atorvastatin - Taken Together | 0 | 16 |
| Total, serious adverse events | Lomitapide & Atorvastatin - Approx. 12 Hours Between | 0 | 16 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lomitapide & Atorvastatin - Taken Together vs Lomitapide & Atorvastatin - Approx. 12 Hours Between: deaths from any cause | Trial comparisons |
| Lomitapide & Atorvastatin - Taken Together vs Lomitapide & Atorvastatin - Approx. 12 Hours Between: serious adverse events | Trial comparisons |
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.
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