MalariaPhase 1IVMPBPKNCT02963324
Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers
A Phase 1 study testing Ivermectin in people with Malaria, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers - a Single-center, Open-label Pharmacokinetics Study
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Ivermectin
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Stromectol
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Single dose of ivermectin 12 mg (as 4 tablets of Stromectol (R) 3 mg) orally Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of ivermectin in whole blood, plasma, and capillary blood
Measured: Intermittent sampling for 72 hours after dosing
Time to maximum concentration (Tmax) of ivermectin in whole blood, plasma, and capillary blood
Measured: Intermittent sampling for 72 hours after dosing
Area under the curve (AUC) of ivermectin in whole blood, plasma, and capillary blood
Measured: Intermittent sampling for 72 hours after dosing
Secondary outcomes (3)
Occurence of adverse events
adverse events (treatment-emergent and/or leading to premature study drug discontinuation).
Measured: For 72 hours after dosing
Laboratory changes
Change from baseline for clinical laboratory tests at the end of the study.
Measured: For 72 hours after dosing
Changes in electrocardiogram (ECG)
Change from baseline in resting 12-channel electrocardiogram (ECG) at the end of the study.
Measured: For 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Krähenbühl, MD PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963324
- Sponsor's protocol ID
- IVMPBPK
- Acronym
- IVMPBPK
- Status last verified
- Jan 2017
- First submitted
- 4 Nov 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers - a Single-center, Open-label Pharmacokinetics Study
- ClinicalTrials.gov ID
- NCT02963324
- Acronym / sponsor ID
- IVMPBPK / IVMPBPK
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: IvermectinSingle dose of ivermectin 12 mg (as 4 tablets of Stromectol (R) 3 mg) orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvermectinAlso: Stromectol | Drug | Ivermectin |
Primary outcome
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
3 secondary outcomes
Occurence of adverse events
Time frame: For 72 hours after dosing
Laboratory changes
Time frame: For 72 hours after dosing
Changes in electrocardiogram (ECG)
Time frame: For 72 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Krähenbühl, MD PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ivermectin in people with Malaria, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) of ivermectin in whole blood, plasma, and capillary blood (time frame: Intermittent sampling for 72 hours after dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.