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

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ClinicalTrials.gov Identifier: NCT01760187
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy Volunteer
Intervention Drug: lomitapide
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Placebo
Hide Arm/Group Description 10 Japanese and 10 Caucasian subjects will receive 10 mg lomitapide. 6 Japanese and 6 Caucasian subjects will receive 20 mg lomitapide. 6 Japanese and 6 Caucasian subjects will receive 40 mg lomitapide. 6 Japanese and 6 Caucasian subjects will receive 60 mg lomitapide. 8 Japanese and 8 Caucasian subjects will receive placebo.
Period Title: Overall Study
Started 20 12 12 12 16
Completed 19 12 12 10 16
Not Completed 1 0 0 2 0
Arm/Group Title Placebo - Japanese Patients Placebo - Caucasian Patients Cohort 1- Japanese Patients Cohort 1 - Caucasian Patients Cohort 2 - Japanese Patients Cohort 2 - Caucasian Patients Cohort 3 - Japanese Patients Cohort 3 - Caucasian Patients Cohort 4 - Japanese Patients Cohort 4 - Caucasian Patients Total
Hide Arm/Group Description

8 Japanese patients will receive placebo, across the cohorts.

(2 at each cohort)

8 Caucasian patients will receive placebo, across the cohorts.

(2 at each cohort)

 10 Japanese subjects will receive 10 mg of lomitapide. 10 Caucasian subjects will receive 10 mg of lomitapide. 6 Japanese subjects will receive 20 mg of lomitapide. 6 Caucasian subjects will receive 20 mg of lomitapide. 6 Japanese subjects will receive 40 mg of lomitapide. 6 Caucasian subjects will receive 40 mg of lomitapide. 6 Japanese subjects will receive 60 mg of lomitapide. 6 Caucasian subjects will receive 60 mg of lomitapide. Total of all reporting groups
Overall Number of Baseline Participants 8 8 10 10 6 6 6 6 6 6 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 10 participants 10 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
10
 100.0%
10
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
72
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 10 participants 10 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 72 participants
34.1  (6.0) 33.6  (7.3) 33.8  (6.0) 31.2  (6.6) 32.2  (5.4) 36.0  (7.5) 32.5  (4.6) 31.2  (9.7) 30.2  (5.4) 37.7  (3.4) 33.3  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 10 participants 10 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 72 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
8
 100.0%
10
 100.0%
10
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
72
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 8 participants 8 participants 10 participants 10 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 72 participants
8 8 10 10 6 6 6 6 6 6 72
1.Primary Outcome
Title Cmax for Lomitapide
Hide Description Maximum observed plasma concentration for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
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)
2.Primary Outcome
Title Tmax for Lomitapide
Hide Description Time to maximum observed concentration for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hr
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)
3.Primary Outcome
Title AUC0-t for Lomitapide
Hide Description Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
29.1  (13.0) 27.5  (11.0) 63.0  (16.0) 54.2  (9.6) 152  (48) 123  (53) 238  (84) 241  (72)
4.Primary Outcome
Title AUC0-∞ for Lomitapide
Hide Description Area under the plasma concentration versus time curve from zero to infinity for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 7 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
37.3  (16.7) 35.9  (15.3) 68.6  (17.4) 64.7  (14.7) 168  (59) 133  (58) 251  (89) 260  (74)
5.Primary Outcome
Title t1/2 for Lomitapide
Hide Description Apparent terminal elimination half-life for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 7 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr
79.5  (5.6) 82.8  (5.9) 50.5  (2.6) 64.3  (20.6) 58.8  (13.3) 56.2  (7.1) 44.9  (5.7) 51.5  (10.9)
6.Primary Outcome
Title Cmax for Lomitapide
Hide Description Maximum observed plasma concentration for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.46  (0.88) 3.31  (2.91) 5.96  (2.79) 4.35  (1.07) 19.7  (6.2) 13.8  (5.1) 29.6  (11.1) 24.6  (9.0)
7.Primary Outcome
Title Tmax for Lomitapide
Hide Description Time to maximum observed concentration for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hr
4
(1 to 4)
4
(2 to 6)
4
(1 to 8)
4
(4 to 4)
4
(4 to 4)
4
(4 to 6)
4
(2 to 6)
4
(2 to 4)
8.Primary Outcome
Title AUC0-t for Lomitapide
Hide Description Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
38.1  (14.1) 44.5  (29.0) 91.3  (29.5) 74.4  (18.8) 263  (64) 204  (79) 388  (86) 403  (130)
9.Primary Outcome
Title t1/2 for Lomitapide
Hide Description Apparent terminal elimination half-life for lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr
62.6  (10.1) 57.6  (8.9) 56.1  (9.9) 53.3  (8.5) 49.7  (11.3) 44.8  (6.4) 48.9  (9.9) 46.5  (6.3)
10.Secondary Outcome
Title Cmax for M1
Hide Description Maximum observed plasma concentration for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.23  (0.23) 1.02  (0.23) 2.27  (0.54) 1.86  (0.54) 4.18  (1.22) 4.20  (1.72) 7.43  (1.88) 5.53  (0.83)
11.Secondary Outcome
Title Tmax for M1
Hide Description Time to maximum observed concentration for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hr
6
(4 to 8)
6
(4 to 6)
5
(4 to 6)
6
(4 to 8)
4
(1 to 8)
6
(4 to 8)
6
(4 to 6)
6
(2 to 8)
12.Secondary Outcome
Title AUC0-t for M1
Hide Description Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
37.1  (9.7) 32.1  (7.9) 64.1  (15.6) 56.7  (18.6) 134  (37) 129  (57) 199  (64) 177  (44)
13.Secondary Outcome
Title AUC0-∞ for M1
Hide Description Area under the plasma concentration versus time curve from zero to infinity for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
38.7  (10.1) 34.0  (8.3) 65.7  (15.9) 59.1  (19.5) 138  (39) 132  (58) 204  (67) 183  (46)
14.Secondary Outcome
Title t1/2 for M1
Hide Description Apparent terminal elimination half-life for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr
37.8  (11.3) 44.0  (14.3) 35.9  (8.7) 35.9  (6.0) 41.5  (4.3) 36.3  (7.9) 39.4  (3.4) 43.6  (4.9)
15.Secondary Outcome
Title Cmax for M3
Hide Description Maximum observed plasma concentration for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
20.0  (4.1) 14.2  (4.8) 35.3  (8.2) 20.0  (5.8) 55.7  (18.3) 50.9  (24.7) 83.9  (34.5) 67.7  (23.8)
16.Secondary Outcome
Title Tmax for M3
Hide Description Time to maximum observed concentration for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hr
4
(2 to 4)
3
(2 to 4)
4
(2 to 4)
4
(2 to 4)
3
(1 to 4)
2
(2 to 4)
4
(4 to 4)
2
(1 to 4)
17.Secondary Outcome
Title AUC0-t for M3
Hide Description Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
265  (53) 185  (86) 486  (145) 263  (115) 760  (169) 824  (355) 1410  (675) 1170  (541)
18.Secondary Outcome
Title AUC0-∞ for M3
Hide Description Area under the plasma concentration versus time curve from zero to infinity for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
276  (55) 196  (91.2) 501  (147) 274  (119) 780  (171) 839  (361) 1430  (693) 1200  (551)
19.Secondary Outcome
Title t1/2 for M3
Hide Description Apparent terminal elimination half-life for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr
56.3  (11.6) 56.9  (10.2) 53.1  (12.9) 51.3  (6.4) 50.5  (14.9) 39.4  (6.1) 47.0  (7.4) 43.8  (5.3)
20.Secondary Outcome
Title Cmax for M1
Hide Description Maximum observed plasma concentration for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.56  (0.44) 2.15  (0.53) 4.36  (0.88) 4.24  (1.30) 9.98  (4.13) 10.7  (3.6) 13.5  (3.4) 12.6  (3.2)
21.Secondary Outcome
Title Tmax for M1
Hide Description Time to maximum observed concentration for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hr
6
(2 to 8)
6
(2 to 6)
6
(4 to 6)
6
(4 to 8)
4
(4 to 8)
6
(4 to 6)
6
(4 to 8)
4
(4 to 8)
22.Secondary Outcome
Title AUC0-t for M1
Hide Description Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
44.3  (8.5) 36.1  (8.5) 73.7  (14.4) 75.3  (25.9) 180  (78) 176  (58) 230  (71) 223  (66)
23.Secondary Outcome
Title t1/2 for M1
Hide Description Apparent terminal elimination half-life for M1 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr
42.4  (9.0) 41.9  (7.5) 41.6  (8.5) 39.7  (4.5) 41.0  (6.6) 36.0  (1.7) 43.5  (7.8) 41.2  (6.2)
24.Secondary Outcome
Title Cmax for M3
Hide Description Maximum observed plasma concentration for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
33.9  (9.3) 24.1  (7.9) 56.4  (15.0) 35.2  (18.8) 76.3  (26.7) 86.4  (27.1) 129  (35) 126  (50)
25.Secondary Outcome
Title Tmax for M3
Hide Description Time to maximum observed concentration for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Median (Full Range)
Unit of Measure: hr
2
(2 to 4)
3
(2 to 6)
3
(2 to 4)
4
(2 to 4)
4
(2 to 4)
4
(2 to 6)
4
(2 to 6)
2
(2 to 4)
26.Secondary Outcome
Title AUC0-t for M3
Hide Description Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
335  (84) 239  (90) 617  (163) 386  (183) 891  (259) 1150  (462) 1640  (664) 1640  (767)
27.Secondary Outcome
Title t1/2 for M3
Hide Description Apparent terminal elimination half-life for M3 metabolite of lomitapide
Time Frame 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with evaluable concentrations
Arm/Group Title Japanese 10 mg Caucasian 10 mg Japanese 20 mg Caucasian 20 mg Japanese 40 mg Caucasian 40 mg Japanese 60 mg Caucasian 60 mg
Hide Arm/Group Description:
Japanese Subjects who received 10 mg Lomitapide
Caucasian Subjects who received 10 mg Lomitapide
Japanese Subjects who received 20 mg Lomitapide
Caucasian Subjects who received 20 mg Lomitapide
Japanese Subjects who received 40 mg Lomitapide
Caucasian Subjects who received 40 mg Lomitapide
Japanese Subjects who received 60 mg Lomitapide
Caucasian Subjects who received 60 mg Lomitapide
Overall Number of Participants Analyzed 10 10 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hr
54.4  (11.0) 44.3  (7.2) 40.4  (6.9) 55.4  (11.5) 41.6  (8.6) 39.3  (7.6) 54.9  (17.4) 41.8  (9.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Japanese Patients Placebo - Caucasian Patients Cohort 1- Japanese Patients Cohort 1 - Caucasian Patients Cohort 2 - Japanese Patients Cohort 2 - Caucasian Patients Cohort 3 - Japanese Patients Cohort 3 - Caucasian Patients Cohort 4 - Japanese Patients Cohort 4 - Caucasian Patients
Hide Arm/Group Description

8 Japanese patients will receive placebo, across the cohorts.

(2 at each cohort)

8 Caucasian patients will receive placebo, across the cohorts.

(2 at each cohort)

 10 Japanese subjects will receive 10 mg of lomitapide. 10 Caucasian subjects will receive 10 mg of lomitapide. 6 Japanese subjects will receive 20 mg of lomitapide. 6 Caucasian subjects will receive 20 mg of lomitapide. 6 Japanese subjects will receive 40 mg of lomitapide. 6 Caucasian subjects will receive 40 mg of lomitapide. 6 Japanese subjects will receive 60 mg of lomitapide. 6 Caucasian subjects will receive 60 mg of lomitapide.
All-Cause Mortality
Placebo - Japanese Patients Placebo - Caucasian Patients Cohort 1- Japanese Patients Cohort 1 - Caucasian Patients Cohort 2 - Japanese Patients Cohort 2 - Caucasian Patients Cohort 3 - Japanese Patients Cohort 3 - Caucasian Patients Cohort 4 - Japanese Patients Cohort 4 - Caucasian Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/8 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Placebo - Japanese Patients Placebo - Caucasian Patients Cohort 1- Japanese Patients Cohort 1 - Caucasian Patients Cohort 2 - Japanese Patients Cohort 2 - Caucasian Patients Cohort 3 - Japanese Patients Cohort 3 - Caucasian Patients Cohort 4 - Japanese Patients Cohort 4 - Caucasian Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo - Japanese Patients Placebo - Caucasian Patients Cohort 1- Japanese Patients Cohort 1 - Caucasian Patients Cohort 2 - Japanese Patients Cohort 2 - Caucasian Patients Cohort 3 - Japanese Patients Cohort 3 - Caucasian Patients Cohort 4 - Japanese Patients Cohort 4 - Caucasian Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/8 (25.00%)      6/8 (75.00%)      4/10 (40.00%)      6/10 (60.00%)      3/6 (50.00%)      4/6 (66.67%)      5/6 (83.33%)      6/6 (100.00%)      6/6 (100.00%)      6/6 (100.00%)    
Gastrointestinal disorders                     
Abdominal Discomfort † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Abdominal Distension † 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 4/6 (66.67%)  4 3/6 (50.00%)  3 5/6 (83.33%)  5
Abdominal Pain † 1  1/8 (12.50%)  1 1/8 (12.50%)  1 1/10 (10.00%)  1 3/10 (30.00%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2
Abdominal Pain Upper † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Change of Bowel Movement † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Constipation † 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Diarrhoea † 1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 4/6 (66.67%)  4 3/6 (50.00%)  3
Dyspepsia † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Mouth Ulceration † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nausea † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 4/6 (66.67%)  4 4/6 (66.67%)  4
Toothache † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Vomiting † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 2/6 (33.33%)  2 1/6 (16.67%)  1
General disorders                     
Catheter Site Related Reaction † 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Fatigue † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  2 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Thirst † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications                     
Arthropod Bite † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Investigations                     
Hepatic Enzyme Increased † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders                     
Decreased Appetite † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
Musculoskeletal and connective tissue disorders                     
Arthralgia † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Back Pain † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Muscle Spasms † 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Pain in Extremity † 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal Chest Pain † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders                     
Headache † 1  1/8 (12.50%)  1 0/8 (0.00%)  0 1/10 (10.00%)  1 2/10 (20.00%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2
Paraesthesia † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
VIITH Nerve Paralysis † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Psychiatric disorders                     
Insomnia † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders                     
Pollakiuria † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Dyspnoea † 1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nasal Congestion † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0
Upper Respiratory Tract Infection † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                     
Rash † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders                     
Dizziness † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Epistaxis † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Haematochezia † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Syncope † 1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA 15.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Described in the contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alison Long, MD - VP Clinical
Organization: Aegerion Pharmaceuticals, Inc.
Phone: 8572425142
EMail: alison.long@aegerion.com
Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01760187    
Other Study ID Numbers: AEGR-733-023
2012-004220-37 ( EudraCT Number )
First Submitted: November 21, 2012
First Posted: January 4, 2013
Results First Submitted: June 23, 2015
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018