HealthyPhase 1NCT00921674
Ivermectin Solution Bioequivalence Study - With Food
A Phase 1 study testing ivermectin in people with Healthy, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken after a standard meal. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Apr 2005
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers
- Aged between 18 and 50 years
- BMI </= 30 kg/m2
- Weight between 50 and 90 kg
- Non-smokers, or smokers of fewer than 10 cigarettes per day
- Clinically normal medical history
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- Clinically normal findings on physical examination
- Clinically normal blood pressure ( >/= 100/60 for males; >/= 90/50 for females; </= 140/90 for both)
- Electrocardiogram recording (12-lead) within the normal range
- Clinically normal findings for haematology and clinical chemistry of blood and urine, or showing clinically insignificant deviations only
- Negative screening results (within the 14 days before study start) for drug of abuse, including opiates, cannabinoids, amphetamines, methamphetamine, benzodiazepines and cocaine
- Negative HIV and Hepatitis B and C tests (within the 14 days before study start)
- Appropriate use of an effective method of contraception (female volunteers only)
- Negative pregnancy test (female volunteers only)
- Ability to comprehend and communicate effectively with the Investigator and staff
- Ability to give written informed consent
Who cannot join
- Illness within 14 days before the start of the study
- Hospitalisation within 3 months before the start of the study (at the discretion of the Investigator)
- Participation in a clinical trial in which blood was taken within 16 weeks before the start of the study
- Participation in a clinical trial in which a volume of blood exceeding 500 ml was taken within 12 months before the start of the study
- Donation of blood or plasma within 90 days before the start of the study
- Any indication of current or previous abuse of alcohol, solvents or drugs
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- Treatment with a full or regular course of medication during the 28 days before the start of the study or with any proscribed medication during the 14 days before the start of the study
- Use of alcohol on study days or within 24 hours prior to commencement of each study period
- Intake of grapefruit products within 7 days before the start of the study
- Intake of methylxanthine-containing beverages within 24 hours prior to each study period
- Intake of quantities of methylxanthine or alcohol-containing beverages which, in the opinion of the Investigator are abnormal (habitually taking more than 5 cups or glasses of tea, coffee, cola, chocolate etc. per day or habitually taking more than 20 g alcohol/day)
- Patient is pregnant, or lactating/breastfeeding (female volunteers only)
- Diet, which in the opinion of the Investigator, deviates from a normal diet (e.g. vegans)
- Patients who have resided in areas of Africa known to be endemic for Onchocerca volvulus (onchocerciasis or river blindness), wuchereria bancrofti (lymphatic filariasis), Loa loa or other microfilaremic disease
- Patients with a known or suspected intestinal helminth infection, such as Strongyloides stercoralis or other intestinal helminth
- Patients with a known hypersensitivity to any component of the Ivermectin product
About this study
Official title: A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Two Formulations of Ivermectin in Healthy Male and Female Volunteers After Food
The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken after a standard meal. The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.
Read the detailed description
Ivermectin is an antiparasitic medicine (i.e. a medicine used to eliminate parasitic worms) for oral administration, and is approved in the US and some other countries in a tablet form. A new liquid formulation of ivermectin has been developed to facilitate dosing. This is a single dose, randomised, crossover study in healthy adult male and female volunteers, with doses taken 20 minutes after a standard breakfast. Doses will be separated by washout period of at least 14 days. Twenty-one blood samples will be taken from each volunteer over 144 hours in each period. Concentrations of Ivermectin in plasma will be measured using a validated chromatographic assay (LC-MS/MS). Standard pharmacokinetic parameters will be obtained and bioequivalence on the basis of rate and extent of drug absorption will be assessed.
- Conditions
- Healthy
- Being tested
- ivermectin
- Keywords
- therapeutic equivalency, pharmacokinetics, food, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivermectinDrug
Also called Stromectol
Each subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | ivermectin Receives: Drug: ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters, including AUC0-t, AUC0-inf, and Cmax
Measured: 21 samples over 144 hours in each period, with a 14-day washout
Secondary outcomes (1)
Pharmacokinetic parameters, including t1/2, Mean residence time (MRT), Terminal Elimination Rate Constant (kel) and Tmax
Measured: 21 samples over 144 hours in each period, with a 14-day washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startFeb 2005
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerry Cottrell, Study director, McNeil UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921674
- Sponsor's protocol ID
- SCO2804
- Status last verified
- Oct 2011
- First submitted
- 15 Jun 2009
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomised, Crossover Study to Compare the Rate and Extent of Absorption of Two Formulations of Ivermectin in Healthy Male and Female Volunteers After Food
- ClinicalTrials.gov ID
- NCT00921674
- Acronym / sponsor ID
- SCO2804
- Conditions
- Healthy
- Keywords
- therapeutic equivalency, pharmacokinetics, food, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 16 Jun 2009 (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 purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken after a standard meal. The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.
Detailed description
Ivermectin is an antiparasitic medicine (i.e. a medicine used to eliminate parasitic worms) for oral administration, and is approved in the US and some other countries in a tablet form. A new liquid formulation of ivermectin has been developed to facilitate dosing. This is a single dose, randomised, crossover study in healthy adult male and female volunteers, with doses taken 20 minutes after a standard breakfast. Doses will be separated by washout period of at least 14 days. Twenty-one blood samples will be taken from each volunteer over 144 hours in each period. Concentrations of Ivermectin in plasma will be measured using a validated chromatographic assay (LC-MS/MS). Standard pharmacokinetic parameters will be obtained and bioequivalence on the basis of rate and extent of drug absorption will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: ivermectinivermectin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy male and female volunteers
- Aged between 18 and 50 years
- BMI </= 30 kg/m2
- Weight between 50 and 90 kg
- Non-smokers, or smokers of fewer than 10 cigarettes per day
Key exclusion criteria (16 listed)
- Illness within 14 days before the start of the study
- Hospitalisation within 3 months before the start of the study (at the discretion of the Investigator)
- Participation in a clinical trial in which blood was taken within 16 weeks before the start of the study
- Participation in a clinical trial in which a volume of blood exceeding 500 ml was taken within 12 months before the start of the study
- Donation of blood or plasma within 90 days before the start of the study
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: StromectolEach subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast. | Drug | Ivermectin |
Primary outcome
Pharmacokinetic parameters, including AUC0-t, AUC0-inf, and Cmax
Time frame: 21 samples over 144 hours in each period, with a 14-day washout
1 secondary outcome
Pharmacokinetic parameters, including t1/2, Mean residence time (MRT), Terminal Elimination Rate Constant (kel) and Tmax
Time frame: 21 samples over 144 hours in each period, with a 14-day washout
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 6 Oct 2011.
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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.
Jerry Cottrell study director
McNeil UK
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ivermectin in people with Healthy, run by Johnson & Johnson Consumer and Personal Products Worldwide.
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 16 inclusion and 16 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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Pharmacokinetic parameters, including AUC0-t, AUC0-inf, and Cmax (time frame: 21 samples over 144 hours in each period, with a 14-day washout). 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 6 Oct 2011.