Trial Outcomes & Findings for Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents (NCT NCT00359281)

NCT ID: NCT00359281

Last Updated: 2018-02-23

Results Overview

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 125 participants
• Primary outcome timeframe: 0 to 24 hour
• Results posted on: 2018-02-23

Participant Flow

The study was performed from 19 May 2006 to 20 November 2007 at 1 medical clinic within the United States.

Participant milestones

Measure	Atorvastatin 20 mg + Lomitapide 10 mg One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Overall Study STARTED	16	15	10	10	10	15	18	15	20
Overall Study COMPLETED	15	15	10	10	10	15	16	15	20
Overall Study NOT COMPLETED	1	0	0	0	0	0	2	0	0

Reasons for withdrawal

Measure	Atorvastatin 20 mg + Lomitapide 10 mg One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Overall Study Adverse Event	1	0	0	0	0	0	1	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	1	0	0

Baseline Characteristics

Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

Baseline characteristics by cohort

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=16 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg n=15 Participants One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg n=10 Participants One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg n=10 Participants One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg n=10 Participants One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg n=15 Participants One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg n=18 Participants One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg n=15 Participants One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg n=20 Participants One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg	Total n=129 Participants Total of all reporting groups
Age, Continuous	26 years STANDARD_DEVIATION 7 • n=5 Participants	29 years STANDARD_DEVIATION 12 • n=7 Participants	29 years STANDARD_DEVIATION 9 • n=5 Participants	31 years STANDARD_DEVIATION 13 • n=4 Participants	24 years STANDARD_DEVIATION 3 • n=21 Participants	27 years STANDARD_DEVIATION 8 • n=10 Participants	31 years STANDARD_DEVIATION 13 • n=115 Participants	27 years STANDARD_DEVIATION 9 • n=6 Participants	29 years STANDARD_DEVIATION 11 • n=6 Participants	28 years STANDARD_DEVIATION 10 • n=64 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=10 Participants	9 Participants n=115 Participants	6 Participants n=6 Participants	9 Participants n=6 Participants	53 Participants n=64 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	10 Participants n=10 Participants	9 Participants n=115 Participants	9 Participants n=6 Participants	11 Participants n=6 Participants	76 Participants n=64 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	15 Participants n=64 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	2 Participants n=6 Participants	4 Participants n=6 Participants	23 Participants n=64 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=10 Participants	11 Participants n=115 Participants	10 Participants n=6 Participants	13 Participants n=6 Participants	82 Participants n=64 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	8 Participants n=64 Participants
Region of Enrollment United States	16 participants n=5 Participants	15 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	10 participants n=21 Participants	15 participants n=10 Participants	18 participants n=115 Participants	15 participants n=6 Participants	20 participants n=6 Participants	129 participants n=64 Participants

PRIMARY outcome

Timeframe: 0 to 24 hour

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=15 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)	110.97 Ratio Interval 98.42 to 125.12	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=15 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Simvastatin	162.25 Ratio Interval 143.19 to 183.86	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=15 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Simvastatin Acid	138.76 Ratio Interval 109.65 to 175.61	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=10 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Total Ezetimibe	105.71 Ratio Interval 92.62 to 120.66	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=10 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Rosuvastatin (Lomitapide 10 mg)	102.05 Ratio Interval 86.0 to 121.1	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=10 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Fenofibric Acid	89.62 Ratio Interval 82.76 to 97.04	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=15 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Atorvastatin Acid (Lomitapide 60 mg)	152.32 Ratio Interval 133.76 to 173.45	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=15 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Rosuvastatin (Lomitapide 60 mg)	132.21 Ratio Interval 111.56 to 156.7	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=20 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Nicotinic Acid	110.22 Ratio Interval 78.28 to 155.18	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 24 hours

Population: Pharmacokinetic

Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=20 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
AUC0-t Nicotinuric Acid	79.15 Ratio Interval 59.82 to 104.72	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Day 8

Population: Intention To Treat

Percent change from Baseline in LDL-C

Outcome measures

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=16 Participants One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg n=15 Participants One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg n=10 Participants One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg n=10 Participants One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg n=10 Participants One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg n=15 Participants One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg n=18 Participants One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg n=15 Participants One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg n=20 Participants One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	-30.99 Percent Change Standard Deviation 14.47	-26.43 Percent Change Standard Deviation 17.77	-28.36 Percent Change Standard Deviation 12.53	-41.74 Percent Change Standard Deviation 10.37	-20.12 Percent Change Standard Deviation 25.56	-66.02 Percent Change Standard Deviation 15.18	-63.20 Percent Change Standard Deviation 18.59	-46.07 Percent Change Standard Deviation 33.12	-20.89 Percent Change Standard Deviation 15.17

Adverse Events

Atorvastatin 20 mg + Lomitapide 10 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Simvastatin 20 mg + Lomitapide 10 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Ezetimibe 10 mg + Lomitapide 10 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Rosuvastatin 20 mg + Lomitapide 10 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Fenofibrate 145 mg + Lomitapide 10 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Atorvastatin 20 mg + Lomitapide 60 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Rosuvastatin 20 mg + Lomitapide 60 mg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Dextrometh-rophan 30 mg + Lomitapide 60 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

ER Niacin 1000 mg + Lomitapide 10 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Atorvastatin 20 mg + Lomitapide 10 mg n=16 participants at risk One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg	Simvastatin 20 mg + Lomitapide 10 mg n=15 participants at risk One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg	Ezetimibe 10 mg + Lomitapide 10 mg n=10 participants at risk One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg	Rosuvastatin 20 mg + Lomitapide 10 mg n=10 participants at risk One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg	Fenofibrate 145 mg + Lomitapide 10 mg n=10 participants at risk One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg	Atorvastatin 20 mg + Lomitapide 60 mg n=15 participants at risk One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg	Rosuvastatin 20 mg + Lomitapide 60 mg n=18 participants at risk One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg	Dextrometh-rophan 30 mg + Lomitapide 60 mg n=15 participants at risk One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg	ER Niacin 1000 mg + Lomitapide 10 mg n=20 participants at risk One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
Gastrointestinal disorders Diarrhoea	18.8% 3/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	26.7% 4/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	30.0% 3/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	46.7% 7/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	50.0% 9/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	26.7% 4/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 2/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Nausea	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	20.0% 2/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	13.3% 2/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	16.7% 3/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	20.0% 3/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 2/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	33.3% 5/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	11.1% 2/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	33.3% 5/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.0% 1/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Vascular disorders Flushing	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	60.0% 12/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Nervous system disorders Headache	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	13.3% 2/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	20.0% 2/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	15.0% 3/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Flatulence	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	20.0% 3/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	11.1% 2/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 2/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Abnormal faeces	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	13.3% 2/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	15.0% 3/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	13.3% 2/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	20.0% 4/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Nervous system disorders Paraesthesia	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	35.0% 7/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	35.0% 7/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Abdominal distension	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	30.0% 3/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Nervous system disorders Dizziness	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	13.3% 2/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 2/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
General disorders Fatigue	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	40.0% 6/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Vomiting	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	11.1% 2/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.0% 1/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Constipation	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
General disorders Chills	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	15.0% 3/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	15.0% 3/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
General disorders Pyrexia	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	13.3% 2/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Cardiac disorders Palpitations	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 2/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Dyspepsia	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Eructation	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Faeces discoloured	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Gastrooesophageal reflux disease	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Renal and urinary disorders Chromaturia	6.2% 1/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Injury, poisoning and procedural complications Laceration	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Faeces hard	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Nervous system disorders Dysgeusia	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	10.0% 1/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
General disorders Infusion site haematoma	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Gastric dilatation	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
Gastrointestinal disorders Haemorrhoids	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
General disorders Infusion site pain	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	5.6% 1/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)
General disorders Malaise	0.00% 0/16 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/10 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/18 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	6.7% 1/15 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)	0.00% 0/20 • From the first dose of study drug (Day 1) to 14 days after the first dose (Day 15)

Additional Information

Mark Sumeray, MD, Chief Medical Officer

Aegerion Pharmaceuticals

Phone: 617-500-7867

Email: msumeray@aegerion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER