A Phase 1 interventional study of lomitapide and Atorvastatin in Effect of Atorvastatin on the Pharmacokinetics of Lomitapide, sponsored by Aegerion Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-10.
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 atorvastatin, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2 primary metabolites, M1 and M3.
This study will be a single center, randomized, open-label, 2-arm study to evaluate the effects of atorvastatin, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy male and female subjects when atorvastatin is administered simultaneously with lomitapide and when it is administered 12 hours after lomitapide.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 \& Day 15) 11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21)
Drug: lomitapide · Drug: Atorvastatin
2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 \& Day 15) 11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)
Drug: lomitapide · Drug: Atorvastatin
20 mg dose
Also known as: Juxtapid
80 mg
Also known as: Lipitor
Cmax
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Tmax
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
AUC0-t
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
AUC0-∞
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
t1/2
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Cmax
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
Tmax
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
AUC0-t
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
AUC0-∞
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
t1/2
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)
Time frame: Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing
| Milestone | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
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)
| 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 | 0.940 ± 34.5 | 2.00 ± 52.9 | 2.24 ± 22.8 | 2.11 ± 31.9 | 32.3 ± 40.6 | 27.2 ± 62.0 |
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)
| 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 | 6.00 (3.00 to 10.0) | 10.0 (3.00 to 23.8) | 6.02 (4.00 to 10.0) | 10.0 (4.00 to 23.8) | 4.00 (3.00 to 12.0) | 6.00 (3.00 to 23.8) |
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)
| 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 | 36.4 ± 38.4 | 71.5 ± 45.3 | 76.8 ± 34.4 | 76.3 ± 36.0 | 434 ± 65.5 | 475 ± 55.0 |
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)
| ng/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered 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 | 1.09 ± 49.8 | 1.39 ± 40.0 | 2.38 ± 25.5 | 2.66 ± 25.4 | 28.5 ± 29.9 | 35.9 ± 27.3 |
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)
| 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-∞ | 40.4 ± 40.8 | 76.7 ± 45.1 | 79.1 ± 34.7 | 78.7 ± 36.3 | 469 ± 68.6 | 487 ± 544 |
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)
| 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 | 50.7 ± 22.1 | 50.4 ± 21.8 | 34.0 ± 17.7 | 35.2 ± 16.2 | 50.2 ± 25.6 | 43.2 ± 18.4 |
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)
| hr | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered 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 | 8.02 (4.00 to 12.0) | 8.00 (5.00 to 11.8) | 8.00 (4.00 to 12.0) | 8.00 (5.07 to 11.8) | 6.00 (3.00 to 10.0) | 5.00 (3.00 to 8.00) |
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)
| ng*hr/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered 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 | 38.8 ± 40.8 | 50.5 ± 26.0 | 68.3 ± 33.0 | 77.6 ± 27.9 | 410 ± 32.6 | 542 ± 31.2 |
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)
| ng*hr/mL | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadminister 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-∞ | 42.8 ± 39.6 | 55.8 ± 25.2 | 70.0 ± 32.8 | 79.2 ± 27.8 | 406 ± 30.8 | 553 ± 32.4 |
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)
| hr | PK of Lomitapide (Lomitapide Alone) | PK of Lomitapide (Coadministered 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 | 52.0 ± 19.5 | 54.7 ± 28.5 | 31.2 ± 24.0 | 32.3 ± 18.2 | 48.0 ± 33.4 | 49.7 ± 21.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lomitapide & Atorvastatin - Taken Together | 0/16 (0%) | 0/16 (0%) | 12/16 (75%) |
| Lomitapide & Atorvastatin - Approx. 12 Hours Between | 0/16 (0%) | 0/16 (0%) | 5/16 (31.3%) |
| Event | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 10/16 | 2/16 |
| Abdominal PainGastrointestinal disorders | 4/16 | 1/16 |
| NauseaGastrointestinal disorders | 3/16 | 0/16 |
| Decreased AppititeMetabolism and nutrition disorders | 3/16 | 0/16 |
| BlisterSkin and subcutaneous tissue disorders | 0/16 | 2/16 |
| HeadacheNervous system disorders | 2/16 | 0/16 |
| Lip DryGastrointestinal disorders | 0/16 | 2/16 |
| ConstipationGastrointestinal disorders | 0/16 | 1/16 |
| ToothacheGastrointestinal disorders | 1/16 | 0/16 |
| Dry SkinSkin and subcutaneous tissue disorders | 1/16 | 0/16 |
| Age, Categorical(Participants) | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 16 | 32 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between | Total |
|---|---|---|---|
| Mean | 41 ± 9.1 | 39 ± 9.5 | 40 ± 9.2 |
| Sex: Female, Male(Participants) | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 8 | 8 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 12 | 13 |
| Not Hispanic or Latino | 15 | 4 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 2 | 10 |
| White | 8 | 13 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Lomitapide & Atorvastatin - Taken Together | Lomitapide & Atorvastatin - Approx. 12 Hours Between | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
Ran from Jan 2014 to primary completion in Mar 2014, 1 month.
Results were first posted in Mar 2020, 6 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: BMS201038 · Atorvastatin
Aegerion Pharmaceuticals, Inc. →