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Trial record 4 of 103 for:    IVERMECTIN

Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers (IVMPBPK)

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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

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Ivermectin Phase 1

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin
Single dose of ivermectin 12 mg (as 4 tablets of Stromectol (R) 3 mg) orally
Drug: Ivermectin
Other Name: Stromectol




Primary Outcome Measures :
  1. Maximum concentration (Cmax) of ivermectin in whole blood, plasma, and capillary blood [ Time Frame: Intermittent sampling for 72 hours after dosing ]
  2. Time to maximum concentration (Tmax) of ivermectin in whole blood, plasma, and capillary blood [ Time Frame: Intermittent sampling for 72 hours after dosing ]
  3. Area under the curve (AUC) of ivermectin in whole blood, plasma, and capillary blood [ Time Frame: Intermittent sampling for 72 hours after dosing ]

Secondary Outcome Measures :
  1. Occurence of adverse events [ Time Frame: For 72 hours after dosing ]
    adverse events (treatment-emergent and/or leading to premature study drug discontinuation).

  2. Laboratory changes [ Time Frame: For 72 hours after dosing ]
    Change from baseline for clinical laboratory tests at the end of the study.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Stephan Krähenbühl, MD PhD University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02963324     History of Changes
Other Study ID Numbers: IVMPBPK
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents