Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers

NCT02963324 | Completed Phase 1 DMC

• 1 other identifier: IVMPBPK
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (3)

• Maximum concentration (Cmax) of ivermectin in whole blood, plasma, and capillary blood

  Intermittent sampling for 72 hours after dosing

• Time to maximum concentration (Tmax) of ivermectin in whole blood, plasma, and capillary blood

  Intermittent sampling for 72 hours after dosing

• Area under the curve (AUC) of ivermectin in whole blood, plasma, and capillary blood

  Intermittent sampling for 72 hours after dosing

Secondary Outcomes (3)

• Occurence of adverse events

  For 72 hours after dosing

• Laboratory changes

  For 72 hours after dosing

• Changes in electrocardiogram (ECG)

  For 72 hours after dosing

Study Arms (1)

Ivermectin

EXPERIMENTAL

Single dose of ivermectin 12 mg (as 4 tablets of Stromectol (R) 3 mg) orally

Drug: Ivermectin

Interventions

Ivermectin DRUG

Also known as: Stromectol

Ivermectin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Malaria

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Stephan Krähenbühl, MD PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 15, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

CH (1)