Bioavailability Pilot Study of Versus W0035 Versus Stromectol

NCT03717558 | Withdrawn Phase 1

• 1 other identifier: W00035 PU 1 02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Concentration of ivermectin

  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

  5 periods of 3 days each

Study Arms (4)

Stromectol R

ACTIVE COMPARATOR

Stromectol R = ivermectin 3mg (tablet)

Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3

ivermectin T1

EXPERIMENTAL

T1= ivermectin low grade particle Size Distribution

Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3

ivermectin T2

EXPERIMENTAL

T2= ivermectin medium grade particle Size Distribution

Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3

ivermectin T3

EXPERIMENTAL

T= ivermectin high grade particle Size Distribution

Drug: ivermectin T1; Drug: ivermectin T2; Drug: ivermectin T3

Interventions

ivermectin T1 DRUG

Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol

Stromectol R; ivermectin T1; ivermectin T2; ivermectin T3

ivermectin T2 DRUG

Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol

Stromectol R; ivermectin T1; ivermectin T2; ivermectin T3

ivermectin T3 DRUG

Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol

Stromectol R; ivermectin T1; ivermectin T2; ivermectin T3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierre Fabre Dermatology: lead

Study Sites (1)

Quotient Clinical

Nottingham, United Kingdom

Location

Study Officials

• Karim Keddad, MD

  Institut de Recherche Pierre Fabre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 24, 2018
• Study Start: April 30, 2018
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)