Bioavailability Pilot Study of Versus W0035 Versus Stromectol

Phase 1

Withdrawn

• Conditions: Healthy Volunteers
• Interventions: Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3

• Registration Number: NCT03717558
• Lead Sponsor: Pierre Fabre Dermatology

Brief Summary

Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol.

PIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-30
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-10
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Study First Posted: 2018-10-24
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• 18.5 ≤ BMI ≤ 30.0 kg/m².
• Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.
• Agree to use effective contraception method

Exclusion Criteria

most specific out of 30.

• History of or current symptomatic orthostatic hypotension
• Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection
• History of or current macroscopic or microscopic hematuria
• Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.
• Organic disorder likely to modify, absorption, distribution or elimination of the medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ivermectin T1	ivermectin T1	T1= ivermectin low grade particle Size Distribution
ivermectin T1	ivermectin T3	T1= ivermectin low grade particle Size Distribution
Stromectol R	ivermectin T2	Stromectol R = ivermectin 3mg (tablet)
Stromectol R	ivermectin T3	Stromectol R = ivermectin 3mg (tablet)
ivermectin T3	ivermectin T2	T= ivermectin high grade particle Size Distribution
Stromectol R	ivermectin T1	Stromectol R = ivermectin 3mg (tablet)
ivermectin T1	ivermectin T2	T1= ivermectin low grade particle Size Distribution
ivermectin T2	ivermectin T1	T2= ivermectin medium grade particle Size Distribution
ivermectin T3	ivermectin T1	T= ivermectin high grade particle Size Distribution
ivermectin T2	ivermectin T2	T2= ivermectin medium grade particle Size Distribution
ivermectin T2	ivermectin T3	T2= ivermectin medium grade particle Size Distribution
ivermectin T3	ivermectin T3	T= ivermectin high grade particle Size Distribution

Primary Outcome Measures

Name	Time	Method
Concentration of ivermectin	5 periods of 3 days each	At each period: 17 blood samples: T0 (Pre-dose), T0 +15min, T0 +30min, T0 +1h, T0+1h30min, T0 +2h, T0 +2h30, T0 +3h, T0 +3h30, T0 +4h, T0 +4h30, T0 +5h, T0 +6h, T0 +12h, T0 +24h, T0 +48h and T0 +72h

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom