Status:
COMPLETED
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Medicines for Malaria Venture
Conditions:
Malaria
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effect of multiple doses of ganaplacide and lumefantrine combination on the substrates of cytochrome P450 (CYP) 3A4 (midazolam), CYP2C8 (repaglinide), CYP2D6...
Detailed Description
This is an open-label, 2-cohort, fixed-sequence, 2-period, crossover, drug-drug interaction (DDI) study to evaluate the effect of multiple doses of ganaplacide and lumefantrine combination on the sing...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05236530
Start Date
March 9 2022
End Date
October 17 2022
Last Update
November 4 2022
Active Locations (1)
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1
Novartis Investigative Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD