HealthyPhase 1NCT02044419

A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled

A Phase 1 study testing lomitapide in people with Healthy, run by Aegerion Pharmaceuticals, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the relative bioavailability of lomitapide when administered by sprinkling the contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral intact capsule dose of 20 mg lomitapide in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: lomitapide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited Kingdom
Study dates: 30 Oct 2013to 23 Dec 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject is a non-smoking healthy male or female, aged between 18 and 40 years of age.
Subject has a BMI of 18.5 - 25 kg/m2.
Subject has total body weight between > 50 kg to ≤ 100 kg.
Subjects must agree to use acceptable methods of contraception.
All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on admission.
In good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history \& full physical examination.
No known history of hypersensitivity or previous intolerance to lomitapide, applesauce, and/or banana.
Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to undergoing any study-related procedures.

Who cannot join

Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) such as a QTcF interval of >450 msec, a history of a prolonged QTc interval or Brugada syndrome.
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, allergic, dermatological, metabolic, neurological, psychiatric or other disease.

Show all 25Show fewer

History or laboratory evidence of Gilbert's syndrome.
Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti-Hepatitis core antibody (anti-HBc Ig G [and anti-HBc IgM if IgG is positive], Hepatitis C antibodies (anti-HCV), and HIV 1 and 2 antibodies, (anti-HIV 1/2).
Use of any drugs of abuse within 6 months prior to admission.
Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol breath test at screening and on admission (Day -1).
History or clinical evidence of alcohol or drug abuse within one year prior to admission.
Mentally handicapped.
Participation in a drug trial within 90 days prior to first drug administration.
Use of any prescription medication within 2 weeks prior to admission (Day -1), with the exception of the oral contraceptive pill.
Use of any substance inducing or inhibiting CYP3A4 enzymes within 30 days prior to admission (Day -1).
Use of any over-the-counter (OTC) medication (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to admission (Day -1), unless deemed acceptable by the Investigator and Sponsor.
Use of alcohol-, grapefruit-, starfruit-, or caffeine-containing foods or beverages within 72 hours prior to admission and through Study Completion.
Donation of more than 500 mL of blood within 90 days prior to drug administration.
Receipt of blood products within 2 months prior to admission.
Poor peripheral venous access.
Use of any tobacco- or nicotine-containing products within 6 months prior to admission (Day -1).
Any acute or chronic condition, scheduled hospitalisation (inclusive of elective surgery during study), or scheduled travel prior to completion of all study procedures.
Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol.
Legal incapacity or limited legal capacity at screening.
Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Richmond Pharmacology Ltd
Croydon, Surrey, CR7 7YE

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-label, Randomised, Crossover Study to Determine the Comparative Bioavailability of 20 mg Lomitapide Where the Contents Have Been Opened and Sprinkled in Applesauce or Mashed Banana ("Sprinkled Contents") to a Single Oral Capsule Dose of 20 mg Lomitapide ("Intact Capsule") in Healthy Subjects

Conditions: Healthy
Being tested: lomitapide
Keywords: Comparative, Bioavailability, lomitapide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lomitapideDrug
Also called Juxtapid, Lojuxta

Study groups in NCT02044419
Study group	Role	What they receive
lomitapide sprinkled in applesauce	Experimental	Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Receives: Drug: lomitapide
lomitapide sprinkled in mashed banana	Experimental	Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Receives: Drug: lomitapide
lomitapide (intact)	Experimental	Intact capsule of 20 mg lomitapide Receives: Drug: lomitapide

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-t
Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites (M1\& M3).
Measured: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose
Cmax
Maximum observed concentration of lomitapide and its metabolites (M1\& M3).
Measured: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose
Tmax
Time to reach maximum plasma concentration of lomitapide and its metabolites (M1\& M3).
Measured: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose
t1/2
Terminal elimination half-life of lomitapide and its metabolites (M1\& M3).
Measured: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose
AUC0-∞
Area under the plasma concentration vs time curve from zero to infinity of lomitapide and its metabolites (M1\& M3).
Measured: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose
λz
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).
Measured: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201323 Dec 2013

First posted24 Jan 2014 (estimated)
Study start30 Oct 2013
Primary completion23 Dec 2013
Study completion23 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02044419
Sponsor's protocol ID: AEGR-733-032
Status last verified: Feb 2018
First submitted: 6 Nov 2013
Last updated: 13 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomised, Crossover Study to Determine the Comparative Bioavailability of 20 mg Lomitapide Where the Contents Have Been Opened and Sprinkled in Applesauce or Mashed Banana ("Sprinkled Contents") to a Single Oral Capsule Dose of 20 mg Lomitapide ("Intact Capsule") in Healthy Subjects
ClinicalTrials.gov ID: NCT02044419
Acronym / sponsor ID: AEGR-733-032
Conditions: Healthy
Keywords: Comparative, Bioavailability, lomitapide
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 30 Oct 2013 (actual)
Primary completion: 23 Dec 2013 (actual)
Study completion: 23 Dec 2013 (actual)
First posted: 24 Jan 2014 (estimated)
Results: Posted 13 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
lomitapide sprinkled in applesauce	Experimental	Drug: lomitapideContents of single 20 mg capsule of lomitapide sprinkled in applesauce
lomitapide sprinkled in mashed banana	Experimental	Drug: lomitapideContents of single 20 mg capsule of lomitapide sprinkled in mashed banana
lomitapide (intact)	Experimental	Drug: lomitapideIntact capsule of 20 mg lomitapide

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Subject is a non-smoking healthy male or female, aged between 18 and 40 years of age.
Subject has a BMI of 18.5 - 25 kg/m2.
Subject has total body weight between > 50 kg to ≤ 100 kg.
Subjects must agree to use acceptable methods of contraception.
All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on admission.

Key exclusion criteria (25 listed)

Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) such as a QTcF interval of >450 msec, a history of a prolonged QTc interval or Brugada syndrome.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lomitapideAlso: Juxtapid, Lojuxta	Drug	lomitapide (intact), lomitapide sprinkled in applesauce, lomitapide sprinkled in mashed banana

Primary outcome

AUC0-t
Time frame: 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).
Cmax
Time frame: 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).
Tmax
Time frame: 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).
t1/2
Time frame: 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).
AUC0-∞
Time frame: 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).
λz
Time frame: 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).

Results and safety

Results posted to the registry on 13 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Applesauce, Mashed Banana, Intact Capsule (ABC)	11	11
Mashed Banana, Intact Capsule, Applesauce (BCA)	10	9
Intact Capsule, Applesauce, Mashed Banana (CAB)	11	10

Primary outcome: AUC0-t

Time frame: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Lomitapide Sprinkled in Applesauce (Treatment A) n = 30	Lomitapide Sprinkled in Mashed Banana (Treatment B) n = 30	Intact Capsule of 20 mg Lomitapide (Treatment C) n = 30
Lomitapide	38.3 (15.2)	40.2 (13.4)	43.6 (17.7)
M1	70.4 (20.2)	72.9 (23.1)	75.2 (22.8)
M3	443 (308)	450 (292)	460 (325)

Population analysed: Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data

Primary outcome: Cmax

Time frame: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Lomitapide Sprinkled in Applesauce (Treatment A) n = 30	Lomitapide Sprinkled in Mashed Banana (Treatment B) n = 30	Intact Capsule of 20 mg Lomitapide (Treatment C) n = 30
Lomitapide	0.986 (0.536)	1.03 (0.463)	1.13 (0.591)
M1	2.52 (0.748)	2.65 (0.813)	2.74 (0.796)
M3	30.2 (15.6)	31.0 (13.3)	28.6 (13.7)

Population analysed: Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data

Primary outcome: Tmax

Time frame: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose. Median (Full Range). Unit: hours

Measure	Lomitapide Sprinkled in Applesauce (Treatment A) n = 30	Lomitapide Sprinkled in Mashed Banana (Treatment B) n = 30	Intact Capsule of 20 mg Lomitapide (Treatment C) n = 30
Lomitapide	4.00 (1.00 to 12.0)	5.00 (1.00 to 12.0)	5.00 (2.00 to 24.0)
M1	5.00 (2.00 to 8.00)	5.00 (2.00 to 6.00)	5.00 (3.00 to 8.00)
M3	2.03 (1.00 to 4.00)	3.00 (1.00 to 5.00)	3.00 (1.00 to 4.00)

Population analysed: Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data

Primary outcome: t1/2

Time frame: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose. Mean (Standard Deviation). Unit: h

Measure	Lomitapide Sprinkled in Applesauce (Treatment A) n = 30	Lomitapide Sprinkled in Mashed Banana (Treatment B) n = 30	Intact Capsule of 20 mg Lomitapide (Treatment C) n = 30
Lomitapide	52.4 (13.3)	47.7 (12.2)	48.8 (10.7)
M1	38.7 (7.56)	37.0 (6.78)	39.1 (6.32)
M3	46.0 (13.1)	45.7 (11.5)	44.0 (11.6)

Population analysed: Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lomitapide Sprinkled in Applesauce (Treatment A)	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30
Lomitapide Sprinkled in Mashed Banana (Treatment B)	0 of 31 (0%)	6 of 31 (19.4%)	0 of 31
Intact Capsule of 20 mg Lomitapide (Treatment C)	0 of 31 (0%)	6 of 31 (19.4%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Sumeray, MD study chair

Aegerion Pharmaceuticals, Inc.

Ulrike Lorch, MD principal investigator

Richmond Phamacology, LTD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lomitapide in people with Healthy, run by Aegerion Pharmaceuticals, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-t (time frame: predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02044419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.