Trial · NCT01915771

Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects

NCT01915771, Phase 1, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2020-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects. Trials, record NCT01915771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01915771

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
NCT number: NCT01915771
Status: Completed
Phases: Phase 1
Enrollment: 15 participants, actual
Lead sponsor: Aegerion Pharmaceuticals, Inc.
Conditions: Intra-subject Variability of Pharmacokinetics
Interventions: lomitapide
First posted: 2013-08-05
Last updated: 2020-03-11
Other registries' IDs: eudract:2013-002692-17
Results first posted: 2020-03-11

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cmax	Pre dose 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	Pre dose 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
Primary	AUC0-t	Pre dose 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	AUC0-∞	Pre dose 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 extrapolated to infinity for lomitapide and its metabolites, M1 \& M3.
Primary	λz	Pre dose 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
Primary	t1/2	Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.	Apparent terminal elimination half-life

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	Cmax	Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.	Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.	ng/mL	MEAN
PRIMARY	Tmax	Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.	Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.	hr	MEDIAN
PRIMARY	AUC0-t	Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.	Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.	ng*hr/mL	MEAN
PRIMARY	AUC0-∞	Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.	Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.	ng*hr/mL	MEAN
PRIMARY	λz	Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.	Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.	1/hr	MEAN
PRIMARY	t1/2	Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.	Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.	hr	MEAN

Source ClinicalTrials.gov

Results by group36

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	Period 1	0.961	Standard Deviation 0.556	ng/mL
Cmax	PK of M1	Period 1	2.34	Standard Deviation 0.593	ng/mL
Cmax	PK of M3	Period 1	23.6	Standard Deviation 7.08	ng/mL
Cmax	PK of Lomitapide	Period 2	1.02	Standard Deviation 0.843	ng/mL
Cmax	PK of M1	Period 2	2.20	Standard Deviation 0.664	ng/mL
Cmax	PK of M3	Period 2	22.8	Standard Deviation 9.33	ng/mL
Tmax	PK of Lomitapide	Period 1	4.0	Full Range 1.00 to 18.0	hr
Tmax	PK of M1	Period 1	5.00	Full Range 3.00 to 10.0	hr
Tmax	PK of M3	Period 1	3.00	Full Range 1.00 to 4.03	hr
Tmax	PK of Lomitapide	Period 2	5.00	Full Range 3.00 to 18.0	hr

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Day 1	STARTED	Lomitapide	15
Day 1	COMPLETED	Lomitapide	14
Day 1	NOT COMPLETED	Lomitapide	1
Day 15	STARTED	Lomitapide	14
Day 15	COMPLETED	Lomitapide	13
Day 15	NOT COMPLETED	Lomitapide	1

Source ClinicalTrials.gov

Adverse events24

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
other	Abdominal Pain	Gastrointestinal disorders	Period 1	1	15
other	Abdominal Pain	Gastrointestinal disorders	Period 2	0	13
other	Diarrhoea	Gastrointestinal disorders	Period 1	3	15
other	Diarrhoea	Gastrointestinal disorders	Period 2	0	13
other	Flatulence	Gastrointestinal disorders	Period 1	1	15
other	Flatulence	Gastrointestinal disorders	Period 2	0	13
other	Nausea	Gastrointestinal disorders	Period 1	2	15
other	Nausea	Gastrointestinal disorders	Period 2	0	13
other	Abdominal Discomfort	Gastrointestinal disorders	Period 1	2	15
other	Abdominal Discomfort	Gastrointestinal disorders	Period 2	1	13

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Period 1	0	15
Total, all-cause mortality	Period 2	0	13
Total, other adverse events	Period 1	4	15
Total, other adverse events	Period 2	1	13
Total, serious adverse events	Period 1	0	15
Total, serious adverse events	Period 2	0	13

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
Period 1 vs Period 2: deaths from any cause	Trial comparisons
Period 1 vs Period 2: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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