Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole

• Status: Not yet recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the effect of multiple doses of itraconazole, a strong CYP3A4/5 inhibitor, on the PK of ganaplacide and lumefantrine in healthy participants. This study will provide data that is relevant for advice regarding possible concomitant medications that are inhibitors of CYP3A4/5 in future clinical studies with ganaplacide and lumefantrine and for potential future labeling considerations

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

Details

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

Criteria

Key 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 to 29.9 kg/m2 inclusive, at Screening.

Key Exclusion Criteria:

• Use of other investigational drugs within 5 half-lives or 30 days prior to first dosing of study treatment, whichever is longer.

• Known family history or known presence of long QT syndrome.

• Known history or current clinically significant arrhythmias.

• History or presence of malignancy of any organ system (other than treated localized basal cell or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of Screening, regardless of whether there is evidence of local recurrence or metastases.

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

• Presence of active or uncontrolled thyroid disease.

• Has had cholecystectomy (gallbladder removed).

Other protocol-defined inclusion/exclusion criteria may apply.