Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole

A Phase I, Open-label, Fixed Sequence, Two-period, Crossover, Drug-drug Interaction Study to Investigate the Interaction Potential of Itraconazole on the Pharmacokinetics of Ganaplacide and Lumefantrine Combination in Healthy Participants

ClinicalTrials.gov Identifier: NCT05084651

Novartis Reference Number: CKAF156A2105

Last Update: Mar 31, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Condition

Malaria

Phase

Phase 1

Overall status

Recruiting

Start date

Nov 18, 2021

Completion date

Apr 18, 2022

Gender

All

Age(s)

18 Years - 55 Years (Adult)

Interventions

Drug

Ganaplacide

Treatment A/Period 1: 400 mg (4 x 100 mg tablets) at Hour 0 on Day 1 Treatment B/Period 2: 400 mg (4 x 100 mg tablets) at Hour 0, approximately 2 hours after itraconazole dosing, on Day 5.

Combination Product

Lumefantrine

Treatment A/Period 1: 480 mg (2 x 240 mg sachets) at Hour 0 on Day 1 Treatment B/Period 2: 480 mg (2 x 240 mg sachets) at Hour 0, approximately 2 hours after itraconazole dosing, on Day 5.

Drug

Itraconazole

200 mg (20 mL of 10 mg/mL oral solution) q.d. on Days 1 to 18

Eligibility 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.