Bioavailability Pilot Study of Versus W0035 Versus Stromectol

Healthy Volunteers Clinical Trial

Official title:

Comparative Bioavailability Pilot Study of 3 W0035 Test Oral Suspensions (Ivermectin 1mg/mL) Versus Stromectol® (Ivermectin, 3 mg Tablet) After Single Oral Administration in Healthy Volunteers. Single Centre, Open Label, Crossover, Randomized, 5-period, 20-sequence, Partial Replicate, Single Dose Design

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03717558
• Other study ID #: W00035 PU 1 02
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 30, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: October 2018
• Source: Pierre Fabre Dermatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ivermectin T1
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
• ivermectin T2
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
• ivermectin T3
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

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermatology

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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