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A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02044419
Recruitment Status : Completed
First Posted : January 24, 2014
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Drug: lomitapide
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Applesauce, Mashed Banana, Intact Capsule (ABC) Mashed Banana, Intact Capsule, Applesauce (BCA) Intact Capsule, Applesauce, Mashed Banana (CAB)
Hide Arm/Group Description First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Second Intervention: Intact capsule of 20 mg lomitapide Third Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce First Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Second Intervention: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Third Intervention: Intact capsule of 20 mg lomitapide
Period Title: First Intervention
Started 11 10 11
Completed 11 9 10
Not Completed 0 1 1
Period Title: Second Intervention
Started 11 9 10
Completed 11 9 10
Not Completed 0 0 0
Period Title: Third Intervention
Started 11 9 10
Completed 11 9 10
Not Completed 0 0 0
Arm/Group Title Applesauce, Mashed Banana, Intact Capsule (ABC) Mashed Banana, Intact Capsule, Applesauce (BCA) Intact Capsule, Applesauce, Mashed Banana (CAB) Total
Hide Arm/Group Description

Contents of single 20 mg capsule of lomitapide sprinkled in applesauce, mashed banana

Capsule taken intact

lomitapide

Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana

Capsule taken intact

lomitapide

Contents of single 20 mg capsule of lomitapide sprinkled in applesauce& mashed banana

Capsule taken intact

lomitapide

 Total of all reporting groups
Overall Number of Baseline Participants 11 10 11 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 11 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
10
 100.0%
11
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 11 participants 32 participants
28.45  (5.837) 25.90  (5.131) 27.91  (3.27) 27.42  (4.746)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 11 participants 32 participants
Female
3
  27.3%
6
  60.0%
6
  54.5%
15
  46.9%
Male
8
  72.7%
4
  40.0%
5
  45.5%
17
  53.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 11 participants 32 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   9.1%
1
   3.1%
Not Hispanic or Latino
11
 100.0%
10
 100.0%
10
  90.9%
31
  96.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 11 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   9.1%
1
  10.0%
1
   9.1%
3
   9.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  27.3%
2
  20.0%
4
  36.4%
9
  28.1%
White
7
  63.6%
6
  60.0%
5
  45.5%
18
  56.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  10.0%
1
   9.1%
2
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 11 participants 10 participants 11 participants 32 participants
11 10 11 32
1.Primary Outcome
Title AUC0-t
Hide Description Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites (M1& M3).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data
Arm/Group Title Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Hide Arm/Group Description:
Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
Intact capsule of 20 mg lomitapide
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
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)
2.Primary Outcome
Title Cmax
Hide Description Maximum observed concentration of lomitapide and its metabolites (M1& M3).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data
Arm/Group Title Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Hide Arm/Group Description:
Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
Intact capsule of 20 mg lomitapide
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: ng/mL
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)
3.Primary Outcome
Title Tmax
Hide Description Time to reach maximum plasma concentration of lomitapide and its metabolites (M1& M3).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data
Arm/Group Title Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Hide Arm/Group Description:
Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
Intact capsule of 20 mg lomitapide
Overall Number of Participants Analyzed 30 30 30
Median (Full Range)
Unit of Measure: hours
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)
4.Primary Outcome
Title t1/2
Hide Description Terminal elimination half-life of lomitapide and its metabolites (M1& M3).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data
Arm/Group Title Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Hide Arm/Group Description:
Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
Intact capsule of 20 mg lomitapide
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: h
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)
5.Primary Outcome
Title AUC0-∞
Hide Description Area under the plasma concentration vs time curve from zero to infinity of lomitapide and its metabolites (M1& M3).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data
Arm/Group Title Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Hide Arm/Group Description:
Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
Intact capsule of 20 mg lomitapide
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Lomitapide 42.5  (17.7) 43.8  (15.3) 47.7  (20.6)
M1 72.8  (20.8) 75.2  (23.7) 77.8  (23.9)
M3 457  (317) 464  (300) 474  (333)
6.Primary Outcome
Title λz
Hide Description 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).
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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data
Arm/Group Title Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Hide Arm/Group Description:
Contents of single 20 mg capsule of lomitapide sprinkled in applesauce
Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana
Intact capsule of 20 mg lomitapide
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: 1/h
Lomitapide 0.0140  (0.00341) 0.0153  (0.00343) 0.0149  (0.00320)
M1 0.0185  (0.00344) 0.0195  (0.00457) 0.0182  (0.00309)
M3 0.0161  (0.00408) 0.0162  (0.00428) 0.0167  (0.00405)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Hide Arm/Group Description Contents of single 20 mg capsule of lomitapide sprinkled in applesauce Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana Intact capsule of 20 mg lomitapide
All-Cause Mortality
Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/31 (0.00%)      0/31 (0.00%)    
Hide Serious Adverse Events
Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/31 (0.00%)      0/31 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lomitapide Sprinkled in Applesauce (Treatment A) Lomitapide Sprinkled in Mashed Banana (Treatment B) Intact Capsule of 20 mg Lomitapide (Treatment C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/30 (16.67%)      6/31 (19.35%)      6/31 (19.35%)    
Eye disorders       
Conjunctival haemorrhage † 1  0/30 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0
Eye swelling † 1  0/30 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain † 1 [1]  0/30 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1
Constipation † 1  0/30 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0
Vomiting † 1  1/30 (3.33%)  1 0/31 (0.00%)  0 1/31 (3.23%)  1
Dry mouth † 1  0/30 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0
Glossodynia † 1  0/30 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1
Oral pain † 1  0/30 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1
General disorders       
Catheter site pain † 1  0/30 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0
Infections and infestations       
Herpes simplex † 1  0/30 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1
Nervous system disorders       
Headache † 1  1/30 (3.33%)  1 0/31 (0.00%)  0 0/31 (0.00%)  0
Renal and urinary disorders       
Polyuria † 1  1/30 (3.33%)  1 0/31 (0.00%)  0 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Nasopharyngitis † 1  1/30 (3.33%)  1 0/31 (0.00%)  0 1/31 (3.23%)  1
Skin and subcutaneous tissue disorders       
Rash † 1  0/30 (0.00%)  0 1/31 (3.23%)  1 1/31 (3.23%)  1
Vascular disorders       
Presyncope † 1  1/30 (3.33%)  1 0/31 (0.00%)  0 0/31 (0.00%)  0
Epistaxis † 1  0/30 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1
1
Term from vocabulary, MedDRA 16.0
†
Indicates events were collected by systematic assessment
[1]
Constipation Vomitting
[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 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: 857-242-5142
EMail: alison.long@aegerion.com
Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02044419    
Other Study ID Numbers: AEGR-733-032
First Submitted: November 6, 2013
First Posted: January 24, 2014
Results First Submitted: June 23, 2015
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018