Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers (IVMPBPK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02963324|
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Ivermectin||Phase 1|
Ivermectin (IVM) is a broad spectrum antiparasitic drug. Recent research indicates that IVM could potentially be used in malaria vector control.
The present study assesses the pharmacokinetic profile of IVM in healthy human volunteers and aims to create a physiologically-based pharmacokinetic model. This model will be used to characterize enterohepatic circulation, serve as a basis for drug-drug and drug-disease-state interaction studies, and simulations of IVM disposition in different populations, with special regard given to adolescents and children. With this, safety in individual administrations can be increased, and mass drug administration programs, e.g. oral IVM as malaria vector control, be simulated and planned to maximize the share of a population that can be included. Capillary blood concentration profiles will also be determined to assess the amount of IVM delivered to mosquitos in malaria vector control programs. Furthermore, this study will validate dried blood spot analytics of IVM which will allow easier procurement of pharmacokinetics (PK) data in the field.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers - a Single-center, Open-label Pharmacokinetics Study|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
Single dose of ivermectin 12 mg (as 4 tablets of Stromectol (R) 3 mg) orally
Other Name: Stromectol
- Maximum concentration (Cmax) of ivermectin in whole blood, plasma, and capillary blood [ Time Frame: Intermittent sampling for 72 hours after dosing ]
- Time to maximum concentration (Tmax) of ivermectin in whole blood, plasma, and capillary blood [ Time Frame: Intermittent sampling for 72 hours after dosing ]
- Area under the curve (AUC) of ivermectin in whole blood, plasma, and capillary blood [ Time Frame: Intermittent sampling for 72 hours after dosing ]
- Occurence of adverse events [ Time Frame: For 72 hours after dosing ]adverse events (treatment-emergent and/or leading to premature study drug discontinuation).
- Laboratory changes [ Time Frame: For 72 hours after dosing ]Change from baseline for clinical laboratory tests at the end of the study.
- Changes in electrocardiogram (ECG) [ Time Frame: For 72 hours after dosing ]Change from baseline in resting 12-channel electrocardiogram (ECG) at the end of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963324
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Stephan Krähenbühl, MD PhD||University Hospital, Basel, Switzerland|