Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz

• Status: Not yet recruiting
• Trial end date: 2022-06-27
• Target enrollment: 0
• Participant gender: All

Summary

This will assess the effect of multiple doses of a moderate inducer of cytochrome P450 (CYP) 3A4 (efavirenz) on the pharmacokinetics (PK) of ganaplacide and lumefantrine combination. Results from this study will provide guidance on prescribing ganaplacide and lumefantrine combination when co-administered with moderate inducers of CYP3A4.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Medicines for Malaria Venture
• Treatments: Efavirenz; Lumefantrine

Criteria

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.

• Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive, at Screening.

• In good health as determined by medical history, physical examination, vital signs, ECG and clinical laboratory tests, at Screening.

• Must weigh at least 50 kg with a body mass index (BMI) within the range of 18.0 to 29.9 kg/m2 inclusive, at Screening.

Exclusion Criteria:

• Known family history or presence of long QT syndrome.

• Known history or current clinically significant arrhythmias.

• Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) exceeding 1.2 x upper limit of normal (ULN) and total bilirubin ≥ 1.5 x ULN or any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or serum bilirubin at Screening or First Baseline.

• History of psychiatric illness.

• Score "yes" on item 4 or item 5 of the suicidal ideation section of the C-SSRS, if this ideation occurred in the past 6 months of Screening, or "yes" on any item of the suicidal behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the suicidal behavior section), if this behavior occurred in the past 2 years of Screening.

• History or presence of seizures.

• History or presence of duodenal ulcer, ulcerative colitis or Crohn's disease.

• Presence of active or uncontrolled thyroid disease.

Additional protocol-defined inclusion / exclusion criteria may apply.