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Trial record 4 of 106 for:    IVERMECTIN

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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE November 4, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE November 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02963324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers
Official Title  ICMJE Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers - a Single-center, Open-label Pharmacokinetics Study
Brief Summary The present study assesses the pharmacokinetic profile of Ivermectin (IVM) in healthy human volunteers and aims to create a physiologically-based pharmacokinetic model. Planned indication is the prevention of malaria transmission.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Malaria
Intervention  ICMJE Drug: Ivermectin
Other Name: Stromectol
Study Arms  ICMJE Experimental: Ivermectin
Single dose of ivermectin 12 mg (as 4 tablets of Stromectol (R) 3 mg) orally
Intervention: Drug: Ivermectin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Age 18-65 years old
  • Caucasian male or female volunteers
  • Body mass index (BMI) 18-30 kg/m2, weight ≥ 50 kg
  • Full mental and legal capacity
  • Signed informed consent prior to any study related procedure
  • Ability to communicate in German or English, sufficient to comprehend and adhere to study protocol
  • Normal physical examination, vital signs, laboratory workup, and electrocardiogram (ECG) (in the opinion of investigator)
  • No history or presence of surgical or medical conditions that might interfere with absorption, distribution, metabolism, and / or elimination of study drug, and / or which might increase its toxic effects (in the opinion of investigator)
  • No ongoing or recent (one month) participation in another clinical trial
  • No loss of blood ≥ 250 ml within the last three months
  • No known hypersensitivity to study drug or any of its constituents
  • No other conditions or circumstances that might interfere with compliance with study protocol (in the opinion of investigator)

Exclusion criteria

  • History or presence of hepatic or biliary disease
  • History of gastrointestinal surgery, specifically cholecystectomy
  • History or presence of alcohol or drug abuse
  • History or presence of neurological or psychiatric comorbidities, including psychological therapy
  • Other clinically significant concomitant disease states (e.g., renal disease, cardiovascular disease, etc.)
  • Intake of prescribed or over-the-counter medications, herbal preparations, and / or vitamin / dietary supplements
  • Clinically relevant history or presence of allergy or asthma (in the opinion of investigator)
  • Female volunteers: pregnancy as confirmed by laboratory assessment; breast-feeding
  • Known hypersensitivity or allergy to class of drugs or the study product
  • Women with intention to become pregnant during the course of the study,
  • Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using two medically reliable methods of contraception for the entire study duration, or who are not using any other method considered sufficiently reliable by the investigator in individual cases, for the duration of the study from screening visit to 30 days after end-of-study-examination.
  • Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02963324
Other Study ID Numbers  ICMJE IVMPBPK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephan Krähenbühl, MD PhD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP