Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
CKAF156A2105
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
Trial arms
Trial start
2021-11-18
Estimated PCD
2022-05-13
Trial end
2022-05-14
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Group 1
Other names:
KAF156
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.
Arms:
Group 1
Other names:
LUM566
Itraconazole
200 mg (20 mL of 10 mg/mL oral solution) q.d. on Days 1 to 18
Arms:
Group 1
Size
19
Primary endpoint
Observed maximum plasma concentration (Cmax) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
Area under the concentration-time curve from time zero (pre-dose) to the 24-hour time point (AUC^0-24) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
Time of maximum observed drug concentration occurrence (Tmax) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
Apparent total body clearance of drug from plasma following extravascular administration (CL/F) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
Apparent volume of distribution during terminal elimination phase following extravascular administration (Vz/F) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
Terminal elimination half-life (T^1/2) for Ganaplacide and Lumefantrine
0 (pre-dose), 0.5, 1, 3, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours (post dose)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2022-10-28

1 organization

3 products

1 indication

Product
Ganaplacide
Indication
Malaria
Product
Lumefantrine
Organization
Novartis Pharmaceuticals
Product
Itraconazole