AzTrials
AzTrials

BioequivalenceEarly Phase 1CHILD-IVITABNCT05477810

Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions

A Early Phase 1 study testing Treatment A (investigational drug) followed by Treatment B (reference drug) and Treatment B (reference drug) followed by Treatment A (investigational drug) in people with Bioequivalence, run by University Children's Hospital Basel at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase I, single-center, open-label, randomized, two-period, two-way crossover, single-dose bioequivalence study in which the active substance ivermectin is administered as a single dose of 12 mg as either CHILD-IVITAB or STROMECTOL during two study drug administration periods. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Bioequivalence
What is being tested?
Treatment A (investigational drug) followed by Treatment B (reference drug) and Treatment B (reference drug) followed by Treatment A (investigational drug)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSwitzerland
Study dates
13 Sep 2022to 15 Dec 2022
Phase
Early 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female aged between 18 and 45 years (inclusive) at screening.
  • Healthy adult females on contraceptives at least 1 month prior to the start of the study until 1 month after the completion of the study and urine pregnancy test at screening and pre-study drug administration negative.
  • No history of alcohol or drug abuse.
  • No history of chronic liver or kidney disease.
  • No clinically significant findings on the physical examination at screening.
  • Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
Show all 13Show fewer
  • Normal blood pressure and heart rate (Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 bpm (inclusive), measured after 5 minutes in the supine position at screening).
  • Hematology and blood chemistry results not deviating from the normal range to a clinically relevant extent at screening. Gilbert's syndrome (increased total and unconjugated bilirubin when fasting) will be accepted if mild.
  • A 12-lead ECG without significant abnormalities (QTc ³450 msec at screening or pronounced sinus bradycardia (<40 bpm/min), even if elicited by sport)
  • Negative urine drug screen (amphetamines, benzodiazepines, cannabis, cocaine, and opiates).
  • Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
  • The participant agrees to be available for scheduled visits.
  • Informed and signed consent obtained prior to any study-mandated procedure (including specific request for HIV serology and hepatitis as well as for urinary screen for drugs).

Who cannot join

  • Eligible participants must meet none of the following exclusion criteria:
  • Known hypersensitivity to any excipients of the drug formulations.
  • Treatment with another investigational drug within 3 months prior to screening.
  • Participation in a clinical study/trial in the previous 3 months unless no treatment taken or large amounts of blood collected
  • History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
  • Significant caffeine consumption defined as > 400 mg per day at screening.
Show all 18Show fewer
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
  • History of moderate or severe allergy or asthma at any time. Allergic rhinitis is acceptable if non symptomatic when starting the study and if symptoms are not anticipated to occur during the first 4 weeks of each period and are not expected to require a corticosteroid treatment.
  • History of cardiovascular dysfunction if considered as clinically relevant (conduction abnormality, arrhythmia, bradycardia, angina pectoris, cardiac hypertrophy unless elicited by training, embolism).
  • Recurrent hypotensive events considered as clinically relevant.
  • Intense sport activities up to 4 days before inclusion
  • Use of any medication the week prior to study or as based on 5 plasma half-life rule (before screening, after screening) and throughout study. Paracetamol is permissible before the study as a rescue medication but only with investigator's permission.
  • Smoking (consumption of ≤5 cigarettes/day or equivalent is acceptable, provided the subject commits to quit entirely during the study)
  • Loss of 350 ml or more of blood or blood donation within 3 months prior to screening.
  • Positive results from the hepatitis serology, except for vaccinated (hepatitis B virus) participants, at screening.
  • Positive results from the HIV serology at screening.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
  • Legal incapacity or limited legal capacity at screening. l

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital CHUV, Service of Clinical Pharmacology

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: Single-center, Open-label, Randomized, Two-period, Two-way Crossover Study to Investigate the Bioequivalence of a Single-dose of 12 mg IVERMECTIN Administered as Orally Disintegrating Mini Tablets (CHILD-IVITAB) Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets (STROMECTOL) in Healthy Adults Under Fasting Conditions

This is a phase I, single-center, open-label, randomized, two-period, two-way crossover, single-dose bioequivalence study in which the active substance ivermectin is administered as a single dose of 12 mg as either CHILD-IVITAB or STROMECTOL during two study drug administration periods. Each treatment will be investigated in the same subgroup of 16 healthy male or female study participants under fasted conditions.

Read the detailed description

Ivermectin is used in humans as an oral antiparasitic agent. Currently approved ivermectin tablets are designed for adult patients. A child-appropriate formulation is not yet available. Ivermectin in suspension is not practicable as the stability is fragile, the shelf-life is very short, and the suspension is affected by UV light exposure. If tablets are offered to infants and young children as crushed or in a suspended form they are prone to imprecise dosing (loss of product after crushing or sedimentation of product after suspension). They are not palatable, and thereby frequently expelled out of the mouth by the child. All above compromise drug-adherence and effectiveness of treatment. In this bioequivalence study in healthy adults, CHILD-IVITAB, a novel orally disintegrating tablet (ODT) formulation containing the active ingredient ivermectin, will be evaluated. CHILD-IVITABs are stable in hot and humid atmosphere and no external agent is required for taste masking or swallowing. This study aims to determine if 12 mg of CHILD-IVITAB administered in a single dose is bioequivalent (with 0.80, 1.25 as the bioequivalence boundaries for AUC0-∞) to 12 mg administered as a single dose of the reference formulation STROMECTOL under fasting conditions. Further this study aims to characterize tolerability of CHILD-IVITAB in healthy adults.

Conditions
Bioequivalence
Being tested
Treatment A (investigational drug) followed by Treatment B (reference drug), Treatment B (reference drug) followed by Treatment A (investigational drug)
Keywords
CHILD-IVITAB, STROMECTOL, Ivermectin, Palatability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment A (investigational drug) followed by Treatment B (reference drug)Drug

    Two drug administration periods (1 and 2), each consisting of administration of Treatment A (investigational drug) followed by Treatment B (reference drug) on Day 1 will be performed. Post administration of the study drug standard PK sampling, measurement of vital signs, adverse events, ECG and VAS as per schedule will be done over a time period of 11 hours. The study participants will thereafter be discharged. The participants will return to the study center at 24, 48, 72 and 96 hours after study drug administration in each treatment period for blood sampling, vital signs and safety assessments as per schedule. The wash-out period between doses will be at least 7 days.

  • Treatment B (reference drug) followed by Treatment A (investigational drug)Drug

    Two drug administration periods (1 and 2), each consisting of administration of Treatment B (reference drug) followed by Treatment A (investigational drug) or on Day 1 will be performed. Post administration of the study drug standard PK sampling, measurement of vital signs, adverse events, ECG and VAS as per schedule will be done over a time period of 11 hours. The study participants will thereafter be discharged. The participants will return to the study center at 24, 48, 72 and 96 hours after study drug administration in each treatment period for blood sampling, vital signs and safety assessments as per schedule. The wash-out period between doses will be at least 7 days.

Study groups in NCT05477810
Study groupRoleWhat they receive
Treatment A (CHILD-IVITAB) before Treatment B (STROMECTOL)ExperimentalA single oral dose of 12 mg CHILD-IVITAB administered as four ODTs of 3 mg (given in the fasted state in the morning). A single oral dose of 12 mg STROMECTOL administered as four tablets of 3 mg (given in the fasted state in the morning). The wash-out period between doses will be at least 7 days.
Receives: Drug: Treatment A (investigational drug) followed by Treatment B (reference drug); Drug: Treatment B (reference drug) followed by Treatment A (investigational drug)
Treatment B (STROMECTOL) before Treatment A (CHILD-IVITAB)Active comparatorA single oral dose of 12 mg STROMECTOL administered as four tablets of 3 mg (given in the fasted state in the morning). A single oral dose of 12 mg CHILD-IVITAB administered as four ODTs of 3 mg (given in the fasted state in the morning). The wash-out period between doses will be at least 7 days.
Receives: Drug: Treatment A (investigational drug) followed by Treatment B (reference drug); Drug: Treatment B (reference drug) followed by Treatment A (investigational drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pharmacokinetics (PK) primary endpoint

    Change in the area under the plasma concentration-time curve from zero to infinity (AUC0-∞) of ivermectin in each treatment period

    Measured: At Baseline, at 30 and 60 minutes, at 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours after study drug administration in each treatment period

Secondary outcomes (10)

  1. The maximum plasma concentration (Cmax) of ivermectin in each treatment period

    The maximum plasma concentration (Cmax) of ivermectin in each treatment period

    Measured: Over a time period of 11 hours after study drug administration in each treatment period

  2. The area under the plasma concentration-time curve from time zero to time t of the last measured concentration above the limit of quantification (AUC0-tlast) of ivermectin in each treatment period

    The area under the plasma concentration-time curve from time zero to time t of the last measured concentration above the limit of quantification (AUC0-tlast) of ivermectin in each treatment period

    Measured: Over a time period of 11 hours after study drug administration in each treatment period

  3. The time to reach maximum plasma concentration (tmax) of ivermectin in each treatment period

    The time to reach maximum plasma concentration (tmax) of ivermectin in each treatment period

    Measured: Over a time period of 11 hours after study drug administration in each treatment period

  4. Supine blood pressure (systolic and diastolic)

    Change from baseline to each time point of measurement during each treatment period as per study schedule for supine blood pressure

    Measured: At Baseline, at 2, 4, 24, 48, 72 and 96 hours after study drug administration in each treatment period and at Day 7-10 of period 2

  5. ECG (conduction changes)

    Change from baseline to each time point of measurement during each treatment period as per study schedule for ECG variables (conduction system)

    Measured: At Baseline, at 2, 4 hours after study drug administration in each treatment period and at Day 7-10 of period 2

  6. Adverse events (AEs) reporting from first drug administration up to end of study (EOS) (number of AEs)

    Adverse events (AEs) reporting from first drug administration up to EOS

    Measured: From Baseline until Day 7-10 of period 2 (between 4 to a maximum of 7 weeks)

  7. Tolerability of Treatments A and B utilizing a visual analogue scale (VAS) for gastrointestinal tract (GIT) (2 items)

    Tolerability of Treatments A and B utilizing a VAS for GIT (2 items) ; (0 = tolerable; 10 = very untolerable)

    Measured: At Baseline, at 30 and 60 minutes, at 2, 3, 4, 6, 10 hours after study drug administration in each treatment period

  8. Tolerability of Treatments A and B utilizing a VAS for central nervous system (CNS) (6 items)

    Tolerability of Treatments A and B utilizing a VAS for CNS (6 items); (0 = tolerable; 10 = very untolerable)

    Measured: At Baseline, at 30 and 60 minutes, at 2, 3, 4, 6, 10 hours after study drug administration in each treatment period

  9. Palatability of Treatments A and B utilizing a VAS (bitterness, sweetness, intensity, and palatability/acceptability)

    Palatability of Treatments A and B utilizing a VAS (bitterness, sweetness, intensity, and palatability/acceptability); (0 = pleasant; 10 = very unpleasant)

    Measured: At 0 and at 30 minutes after study drug administration in each treatment period

  10. Heart rate

    Change from baseline to each time point of measurement during each treatment period as per study schedule for Heart rate

    Measured: At Baseline, at 2, 4, 24, 48, 72 and 96 hours after study drug administration in each treatment period and at Day 7-10 of period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start13 Sep 2022
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
open-label, randomized, two-period, two-way crossover, single-dose bioequivalence study
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477810
Sponsor's protocol ID
2022-01276; ks21Pfister2
Acronym
CHILD-IVITAB
Status last verified
Dec 2022
First submitted
20 Jul 2022
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Treatment A (investigational drug) followed by Treatment B (reference drug) and Treatment B (reference drug) followed by Treatment A (investigational drug) in people with Bioequivalence, run by University Children's Hospital Basel 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 13 inclusion and 18 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 22 Dec 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

pharmacokinetics (PK) primary endpoint (time frame: At Baseline, at 30 and 60 minutes, at 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours after study drug administration in each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05477810.

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 22 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in