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).
Lomitapide
Group
Value
95% CI
Lomitapide Sprinkled in Applesauce (Treatment A)
0.0140
± 0.00341
Lomitapide Sprinkled in Mashed Banana (Treatment B)
0.0153
± 0.00343
Intact Capsule of 20 mg Lomitapide (Treatment C)
0.0149
± 0.00320
M1
Group
Value
95% CI
Lomitapide Sprinkled in Applesauce (Treatment A)
0.0185
± 0.00344
Lomitapide Sprinkled in Mashed Banana (Treatment B)
0.0195
± 0.00457
Intact Capsule of 20 mg Lomitapide (Treatment C)
0.0182
± 0.00309
M3
Group
Value
95% CI
Lomitapide Sprinkled in Applesauce (Treatment A)
0.0161
± 0.00408
Lomitapide Sprinkled in Mashed Banana (Treatment B)
0.0162
± 0.00428
Intact Capsule of 20 mg Lomitapide (Treatment C)
0.0167
± 0.00405
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lomitapide Sprinkled in Applesauce (Treatment A)
Serious: 0/30 (0%)
Deaths: 0/30
Lomitapide Sprinkled in Mashed Banana (Treatment B)
To compare the relative bioavailability of lomitapide when administered by sprinkling the contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral intact capsule dose of 20 mg lomitapide in healthy subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT02173158 — Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
· Phase 3
· completed
NCT02080468 — Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
· Phase 1
· completed
NCT02080455 — Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
· Phase 1
· completed
NCT01915771 — Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
· Phase 1
· completed
NCT01760187 — Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
· Phase 1
· completed
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Other Aegerion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT04026178 — Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
· Phase 4
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NCT02173158 — Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
· Phase 3
· completed
NCT02080468 — Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
· Phase 1
· completed
NCT02080455 — Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
· Phase 1
· completed
NCT01915771 — Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
· Phase 1
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aegerion Pharmaceuticals, Inc.
Last refreshed: 13 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02044419.