Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects (NCT04080895) | Clinical Trial Compass
TerminatedPhase 1
Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects
Stopped: The decision was made due to the expired investigational drug and regulatory changes by the Thai FDA, along with increased importation costs. The research team and investigational drug sponsor agreed to seek approval for early project termination.
Thailand8 participantsStarted 2022-11-01
Plain-language summary
This is an open-label pharmacokinetic study in 16 healthy Thai subjects. To assess the safety and tolerability and pharmacological interactions of the combination of artemether-lumefantrine and amodiaquine.
This study is funded by Prof White's WT PRF. The Welcome Trust grant reference number is B9R04920.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
✓. Male or female non-smoker aged between 18 years to 60 years.
✓. A female is eligible to enter and participate in this study if she is:
✓. A male is eligible to enter and participate in this study if he: agrees to abstain from sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
✓. Normal electrocardiogram (ECG) with QTc \<450 msec.
✓. Willingness and ability to comply with the study protocol for the duration of the trial.
Exclusion criteria
✕. Females who are pregnant, trying to get pregnant, or are lactating.
✕. The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
What they're measuring
1
Area under the concentration-time curve (AUC0-∞)
Timeframe: approximately 6 - 12 months
2
Area under the concentration-time curve AUC (0-last)
✕. A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
✕. Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death.
✕. Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) \<70 mL/min as determined by CKD-EPI equation
✕. History of alcohol or substance abuse or dependence within 6 months of the study.
✕. Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety; the investigator will take advice from the manufacturer representative as necessary.
✕. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 x half-life, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.