Healthy VolunteerPhase 1NCT01760187

Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C

A Phase 1 study testing lomitapide in people with Healthy Volunteer, 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

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of orally administered lomitapide in healthy male Japanese and Caucasian subjects with elevated LDL-C. Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: lomitapide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited Kingdom
Study dates: 7 Nov 2012to 3 Jun 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 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. Subject is a healthy male or female, Caucasian or Japanese, aged 20 - 45 years, inclusive, at screening.
2. Subject has a BMI of 18.5 - 30 kg/m2 inclusive at screening.
3. Subjects must have a screening LDL-C measurement and the mean of Day 5 and Day 6 measurements greater than or equal to 110mg/dL.
4. Subjects must agree to use acceptable methods of contraception (details provided in the protocol)
5. 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.
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analysis.
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric or other disease.
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) at screening.
Confirmed positive results from urine drug screen or from the alcohol breath test at screening and on admission (Day -1).

Show all 18Show fewer

History or clinical evidence of alcohol or drug abuse.
Mentally handicapped.
Participation in a drug trial within 90 days prior to first drug administration.
Use of any medication (including over-the-counter (OTC) medication) within 2 weeks prior to admission (Day -1) or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment periods.
Use of any substance inhibiting CYP3A4 enzymes within 2 weeks prior to admission (Day -1).
Donation of more than 500 mL of blood within 90 days prior to drug administration.
Subjects who smoke more than 10 cigarettes or equivalent amount of tobacco per day and/or who cannot stop smoking for the duration of the study whilst in the CPU.
Treatment with herbal supplements during the 7 days prior to dosing, or use of vitamins during 48 hours prior to admission (Day -1).
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.
If female, subject was pregnant or lactating (females of child bearing potential must have negative pregnancy tests at screening and admission).

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 Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Lomitapide in Japanese and Caucasian Volunteers With Elevated Low-density-lipoprotein(LDL-C)

Conditions: Healthy Volunteer
Being tested: lomitapide

What participants receive

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

lomitapideDrug

Study groups in NCT01760187
Study group	Role	What they receive
Cohort 1	Experimental	12 Japanese and 12 Caucasian subjects. 10 out of 12 will receive 10 mg lomitapide and 2 will receive placebo. Receives: Drug: lomitapide
Cohort 2	Experimental	8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 20 mg lomitapide and 2 will receive placebo. Receives: Drug: lomitapide
Cohort 3	Experimental	8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 40 mg lomitapide and 2 will receive placebo. Receives: Drug: lomitapide
Cohort 4	Experimental	8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 60 mg lomitapide and 2 will receive placebo. Receives: Drug: lomitapide

What is being measured

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

Cmax for Lomitapide
Maximum observed plasma concentration for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Tmax for Lomitapide
Time to maximum observed concentration for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-t for Lomitapide
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-∞ for Lomitapide
Area under the plasma concentration versus time curve from zero to infinity for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
t1/2 for Lomitapide
Apparent terminal elimination half-life for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Cmax for Lomitapide
Maximum observed plasma concentration for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Tmax for Lomitapide
Time to maximum observed concentration for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
AUC0-t for Lomitapide
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
t1/2 for Lomitapide
Apparent terminal elimination half-life for lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27

Secondary outcomes (18)

Cmax for M1
Maximum observed plasma concentration for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Tmax for M1
Time to maximum observed concentration for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-t for M1
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-∞ for M1
Area under the plasma concentration versus time curve from zero to infinity for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
t1/2 for M1
Apparent terminal elimination half-life for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Cmax for M3
Maximum observed plasma concentration for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Tmax for M3
Time to maximum observed concentration for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-t for M3
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-∞ for M3
Area under the plasma concentration versus time curve from zero to infinity for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
t1/2 for M3
Apparent terminal elimination half-life for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Cmax for M1
Maximum observed plasma concentration for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Tmax for M1
Time to maximum observed concentration for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
AUC0-t for M1
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
t1/2 for M1
Apparent terminal elimination half-life for M1 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Cmax for M3
Maximum observed plasma concentration for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Tmax for M3
Time to maximum observed concentration for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
AUC0-t for M3
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
t1/2 for M3
Apparent terminal elimination half-life for M3 metabolite of lomitapide
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27

Timeline

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

7 Nov 20123 Jun 2013

First posted4 Jan 2013 (estimated)
Study start7 Nov 2012
Primary completion3 Jun 2013
Study completion3 Jun 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 Healthy VolunteerStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01760187
Sponsor's protocol ID: AEGR-733-023
Other IDs: 2012-004220-37
Status last verified: Nov 2018
First submitted: 21 Nov 2012
Last updated: 20 Nov 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 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Lomitapide in Japanese and Caucasian Volunteers With Elevated Low-density-lipoprotein(LDL-C)
ClinicalTrials.gov ID: NCT01760187
Acronym / sponsor ID: AEGR-733-023
Conditions: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Richmond Pharmacology Limited
Study start: 7 Nov 2012 (actual)
Primary completion: 3 Jun 2013 (actual)
Study completion: 3 Jun 2013 (actual)
First posted: 4 Jan 2013 (estimated)
Results: Posted 20 Nov 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Cohort 1	Experimental	Drug: lomitapide12 Japanese and 12 Caucasian subjects. 10 out of 12 will receive 10 mg lomitapide and 2 will receive placebo.
Cohort 2	Experimental	Drug: lomitapide8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 20 mg lomitapide and 2 will receive placebo.
Cohort 3	Experimental	Drug: lomitapide8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 40 mg lomitapide and 2 will receive placebo.
Cohort 4	Experimental	Drug: lomitapide8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 60 mg lomitapide and 2 will receive placebo.

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

1. Subject is a healthy male or female, Caucasian or Japanese, aged 20 - 45 years, inclusive, at screening.
2. Subject has a BMI of 18.5 - 30 kg/m2 inclusive at screening.
3. Subjects must have a screening LDL-C measurement and the mean of Day 5 and Day 6 measurements greater than or equal to 110mg/dL.
4. Subjects must agree to use acceptable methods of contraception (details provided in the protocol)
5. 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.

Key exclusion criteria (18 listed)

Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analysis.
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric or other disease.
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) at screening.

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
lomitapide	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4

Primary outcome

Cmax for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Maximum observed plasma concentration for lomitapide
Tmax for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Time to maximum observed concentration for lomitapide
AUC0-t for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide
AUC0-∞ for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Area under the plasma concentration versus time curve from zero to infinity for lomitapide
t1/2 for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Apparent terminal elimination half-life for lomitapide
Cmax for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Maximum observed plasma concentration for lomitapide
Tmax for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Time to maximum observed concentration for lomitapide
AUC0-t for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide
t1/2 for Lomitapide
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Apparent terminal elimination half-life for lomitapide

18 secondary outcomes

Cmax for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Tmax for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-t for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-∞ for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
t1/2 for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Cmax for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Tmax for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-t for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
AUC0-∞ for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
t1/2 for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Cmax for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Tmax for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
AUC0-t for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
t1/2 for M1
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Cmax for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Tmax for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
AUC0-t for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
t1/2 for M3
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27

Results and safety

Results posted to the registry on 20 Nov 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
Cohort 1	20	19
Cohort 2	12	12
Cohort 3	12	12
Cohort 4	12	10
Placebo	16	16

Primary outcome: Cmax for Lomitapide

Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7. Mean (Standard Deviation). Unit: ng/mL

Measure	Japanese 10 mg n = 10	Caucasian 10 mg n = 10	Japanese 20 mg n = 6	Caucasian 20 mg n = 6	Japanese 40 mg n = 6	Caucasian 40 mg n = 6	Japanese 60 mg n = 6	Caucasian 60 mg n = 6
Value	0.570 (0.285)	0.436 (0.166)	1.70 (0.49)	1.01 (0.17)	3.93 (0.75)	3.00 (1.52)	8.29 (3.44)	5.75 (1.78)

Population analysed: All subjects with evaluable concentrations

Primary outcome: Tmax for Lomitapide

Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7. Median (Full Range). Unit: hr

Measure	Japanese 10 mg n = 10	Caucasian 10 mg n = 10	Japanese 20 mg n = 6	Caucasian 20 mg n = 6	Japanese 40 mg n = 6	Caucasian 40 mg n = 6	Japanese 60 mg n = 6	Caucasian 60 mg n = 6
Value	4 (2 to 6)	5 (2 to 12)	9 (4 to 12)	6 (2 to 12)	4 (2 to 6)	5 (4 to 8)	6 (4 to 6)	5 (2 to 6)

Population analysed: All subjects with evaluable concentrations

Primary outcome: AUC0-t for Lomitapide

Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Japanese 10 mg n = 10	Caucasian 10 mg n = 10	Japanese 20 mg n = 6	Caucasian 20 mg n = 6	Japanese 40 mg n = 6	Caucasian 40 mg n = 6	Japanese 60 mg n = 6	Caucasian 60 mg n = 6
Value	29.1 (13.0)	27.5 (11.0)	63.0 (16.0)	54.2 (9.6)	152 (48)	123 (53)	238 (84)	241 (72)

Population analysed: All subjects with evaluable concentrations

Primary outcome: AUC0-∞ for Lomitapide

Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Japanese 10 mg n = 7	Caucasian 10 mg n = 10	Japanese 20 mg n = 6	Caucasian 20 mg n = 6	Japanese 40 mg n = 6	Caucasian 40 mg n = 6	Japanese 60 mg n = 6	Caucasian 60 mg n = 6
Value	37.3 (16.7)	35.9 (15.3)	68.6 (17.4)	64.7 (14.7)	168 (59)	133 (58)	251 (89)	260 (74)

Population analysed: AUC0-∞ and t1/2 were not calculated for 3 subjects in the Japanese 10mg arm because the estimated t1/2 was being much longer than half of the total sampling time.

18 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Japanese Patients	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Placebo - Caucasian Patients	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Cohort 1- Japanese Patients	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Cohort 1 - Caucasian Patients	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Cohort 2 - Japanese Patients	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 2 - Caucasian Patients	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Cohort 3 - Japanese Patients	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 3 - Caucasian Patients	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 4 - Japanese Patients	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 4 - Caucasian Patients	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 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.

Ulrike Lorch, MD FRCA FFPM principal investigator

Richmond Pharmacology Limited

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 Volunteer, 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 5 inclusion and 18 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 20 Nov 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 20 Nov 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?

Cmax for Lomitapide (time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7). The study lists 9 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 NCT01760187.

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 20 Nov 2018.