A Phase 1 interventional study of lomitapide and EE/norgestimate in Healthy, sponsored by Aegerion Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by Aegerion Pharmaceuticals, Inc. (part of Chiesi Farmaceutici S.p.A.) · Phase 1, Interventional, and Other
The primary objective of this study is to assess the effect of ethinyl estradiol (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and 2 primary metabolites, M1 and M3.
This study will be a single center, randomized, open-label, 2 arm study to evaluate the effects of EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy female subjects when EE/norgestimate is administered simultaneously with lomitapide and when administration is separated by 12 hours.
Aegerion Pharmaceuticals, Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.
First submitted before Aegerion Pharmaceuticals, Inc. became part of Chiesi Farmaceutici S.p.A..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lomitapide \& EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28)
Drug: lomitapide · Drug: EE/norgestimate
Lomitapide \& EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29)
Drug: lomitapide · Drug: EE/norgestimate
20 mg
Also known as: Juxtapid
Drug page: Norgestimate
1x0.035-mg EE/0.25-mg norgestimate tablet
Also known as: Ortho Cylclen
Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)
Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)
Apparent terminal elimination half-life of lomitapide and its metabolites, M1 \& M3.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing
| Milestone | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart |
|---|---|---|
| Started | 16 | 16 |
| Completed | 14 | 14 |
| Not completed | 2 | 2 |
Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3
| ng/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered Simultaneously) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered Simultaneously) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered Simultaneously) |
|---|---|---|---|---|---|---|
| Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1.03 ± 39.1 | 1.39 ± 58.4 | 2.96 ± 27.0 | 2.95 ± 19.4 | 36.3 ± 32.1 | 34.0 ± 27.9 |
Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
| hr | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered Simultaneously) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered Simultaneously) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered Simultaneously) |
|---|---|---|---|---|---|---|
| Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 6.00 (4.00 to 12.0) | 5.00 (1.00 to 18.0) | 8.28 (5.00 to 12.0) | 6.00 (2.00 to 12.0) | 5.02 (3.00 to 12.0) | 3.97 (1.00 to 6.00) |
Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 \& M3.
| ng*hr/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered Simultaneously) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered Simultaneously) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered Simultaneously) |
|---|---|---|---|---|---|---|
| AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 33.5 ± 35.0 | 42.7 ± 49.5 | 89.3 ± 35.6 | 96.8 ± 32.1 | 456 ± 41.2 | 371 ± 36.1 |
Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 \& M3.
| ng*hr/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered Simultaneously) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered Simultaneously) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered Simultaneously) |
|---|---|---|---|---|---|---|
| AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 36.5 ± 34.8 | 46.5 ± 49.1 | 91.4 ± 35.8 | 99.4 ± 32.4 | 463 ± 40.9 | 377 ± 36.0 |
Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \& M3.
| hr | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered Simultaneously) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered Simultaneously) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered Simultaneously) |
|---|---|---|---|---|---|---|
| t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 51.0 ± 16.1 | 53.6 ± 19.0 | 32.5 ± 20.3 | 36.8 ± 30.3 | 38.3 ± 32.7 | 39.8 ± 26.2 |
Maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.
| ng/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Codministered 12 Hours Apart) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered 12 Hours Apart) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered 12 Hours Apart) |
|---|---|---|---|---|---|---|
| Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1.05 ± 50.7 | 1.39 ± 56.5 | 2.87 ± 20.6 | 3.04 ± 22.8 | 37.8 ± 26.2 | 33.0 ± 28.0 |
Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.
| hr | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Codministered 12 Hours Apart) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered 12 Hours Apart) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered 12 Hours Apart) |
|---|---|---|---|---|---|---|
| Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 8.00 (5.00 to 10.0) | 8.00 (3.00 to 11.8) | 9.07 (5.00 to 12.0) | 8.00 (3.00 to 11.9) | 6.00 (5.00 to 10.0) | 5.50 (2.00 to 8.40) |
Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 \& M3.
| ng*hr/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Codministered 12 Hours Apart) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered 12 Hours Apart) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered 12 Hours Apart) |
|---|---|---|---|---|---|---|
| AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 37.6 ± 49.9 | 46.5 ± 55.1 | 92.3 ± 31.1 | 93.7 ± 34.2 | 520 ± 30.1 | 377 ± 31.9 |
Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 \& M3.
| ng*hr/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Codministered 12 Hours Apart) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered 12 Hours Apart) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered 12 Hours Apart) |
|---|---|---|---|---|---|---|
| AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 41.1 ± 50.9 | 51.2 ± 55.3 | 94.5 ± 31.3 | 96.4 ± 34.6 | 528 ± 30.0 | 383 ± 31.7 |
Apparent terminal elimination half-life of lomitapide and its metabolites, M1 \& M3.
| hr | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Codministered 12 Hours Apart) | PK of M1 (Lomitapide Alone) | PK of M1 (Coadministered 12 Hours Apart) | PK of M3 (Lomitapide Alone) | PK of M3 (Coadministered 12 Hours Apart) |
|---|---|---|---|---|---|---|
| t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 51.0 ± 22.2 | 52.0 ± 16.1 | 36.2 ± 21.0 | 37.2 ± 19.1 | 38.0 ± 28.0 | 33.6 ± 23.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lomitapide & EE/Norgestimate - Taken Together | 0/16 (0%) | 0/16 (0%) | 8/16 (50%) |
| Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 0/16 (0%) | 0/16 (0%) | 7/16 (43.8%) |
| Event | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart |
|---|---|---|
| NauseaGastrointestinal disorders | 4/16 | 1/16 |
| VomittingGastrointestinal disorders | 4/16 | 1/16 |
| HeadacheNervous system disorders | 2/16 | 3/16 |
| Procedural dizzinessInjury, poisoning and procedural complications | 1/16 | 2/16 |
| Procedural NauseaInjury, poisoning and procedural complications | 0/16 | 2/16 |
| Vessel Punction Site PainGeneral disorders | 2/16 | 0/16 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/16 | 2/16 |
| DysmenorrhoeaReproductive system and breast disorders | 2/16 | 0/16 |
| LacerationInjury, poisoning and procedural complications | 1/16 | 0/16 |
| InsomniaPsychiatric disorders | 0/16 | 1/16 |
| Age, Categorical(Participants) | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 16 | 32 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | Total |
|---|---|---|---|
| Mean | 30 ± 6.4 | 29 ± 5.7 | 29 ± 6.0 |
| Sex: Female, Male(Participants) | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | Total |
|---|---|---|---|
| Female | 16 | 16 | 32 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 10 | 13 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 10 | 19 |
| White | 7 | 5 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Lomitapide & EE/Norgestimate - Taken Together | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
Ran from Feb 2014 to primary completion in Apr 2014, 2 months.
Results were first posted in Mar 2019, 4 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: BMS201038 · Norgestimate
Aegerion Pharmaceuticals, Inc. →