Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05477810
Other study ID # 2022-01276; ks21Pfister2
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 13, 2022
Est. completion date December 15, 2022

Study information

Verified date December 2022
Source University Children's Hospital Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Each treatment will be investigated in the same subgroup of 16 healthy male or female study participants under fasted conditions.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 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. - 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). Exclusion Criteria: - 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. - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Treatment A (investigational drug) followed by Treatment B (reference 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)
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.

Locations

Country Name City State
Switzerland University Hospital CHUV, Service of Clinical Pharmacology Lausanne

Sponsors (3)

Lead Sponsor Collaborator
University Children's Hospital Basel Galvita AG, Switzerland, Permamed AG, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary pharmacokinetics (PK) primary endpoint Change in the area under the plasma concentration-time curve from zero to infinity (AUC0-8) of ivermectin in each treatment period 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 The maximum plasma concentration (Cmax) of ivermectin in each treatment period The maximum plasma concentration (Cmax) of ivermectin in each treatment period Over a time period of 11 hours after study drug administration in each treatment period
Secondary 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 Over a time period of 11 hours after study drug administration in each treatment period
Secondary 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 Over a time period of 11 hours after study drug administration in each treatment period
Secondary 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 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
Secondary 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) At Baseline, at 2, 4 hours after study drug administration in each treatment period and at Day 7-10 of period 2
Secondary 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 From Baseline until Day 7-10 of period 2 (between 4 to a maximum of 7 weeks)
Secondary 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) At Baseline, at 30 and 60 minutes, at 2, 3, 4, 6, 10 hours after study drug administration in each treatment period
Secondary 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) At Baseline, at 30 and 60 minutes, at 2, 3, 4, 6, 10 hours after study drug administration in each treatment period
Secondary 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) At 0 and at 30 minutes after study drug administration in each treatment period
Secondary Heart rate Change from baseline to each time point of measurement during each treatment period as per study schedule for Heart rate 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
See also
  Status Clinical Trial Phase
Completed NCT03705533 - Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State Phase 1
Completed NCT04938856 - Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions Phase 1
Completed NCT03646331 - Bioequivalence of Imeglimin Tablet Formulations Phase 1
Completed NCT04564456 - A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05197517 - Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition Phase 1
Completed NCT03702894 - Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions Phase 1
Withdrawn NCT02894515 - Bioequivalence Study of Idalopirdine in Healthy Subjects Phase 1
Completed NCT03018015 - Ibuprofen Bioavailability Trial With Oral Single Dose Administration. Phase 1
Completed NCT02206295 - Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg Phase 1
Completed NCT01331993 - A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation Phase 1
Completed NCT01260805 - A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers. Phase 1
Recruiting NCT06066112 - Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body Phase 1
Completed NCT04546256 - A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05083325 - Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product Phase 1
Completed NCT05061901 - Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions Phase 1
Recruiting NCT04138888 - A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions Phase 1
Completed NCT05145621 - Oral Bio-equivalence Study Phase 1
Completed NCT06124560 - Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. Phase 1
Completed NCT03340753 - Bioavailability of KBP-5074 Tablet vs Capsule Formulations Phase 1
Completed NCT04230070 - Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product Phase 1