Phase 1 PK study of ivermectin (W0035) oral suspensions (QCL118100)
Research type
Research Study
Full title
Comparative bioavailability pilot study of W0035 Test oral suspensions (ivermectin 1mg/mL) versus Stromectol® (ivermectin, 3 mg tablet) after single oral administration in healthy volunteers
IRAS ID
231352
Contact name
Marine Fagard
Contact email
Sponsor organisation
Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre
Eudract number
2017-001822-17
Duration of Study in the UK
0 years, 3 months, 3 days
Research summary
The Sponsor is developing three different formulations (recipes) of the study drug, ivermectin, for the potential treatment of a group of diseases caused by parasites. Parasitic diseases are highly infectious and infect both adults and children. Ivermectin is already available and used by patients as a tablet called Stromectol®.
The study will try to identify the relative level of ivermectin present in the blood after a single dose of each of the three new ivermectin formulations compared to the already available Stromectol® tablet. The new ivermectin formulations have been designed as powders (each with a different particle size) to be mixed with water and given by mouth (liquid medicines). The safety and tolerability of the ivermectin liquid medicines will also be investigated.
The study will consist of 1 part involving up to 20 healthy male subjects. The subjects will attend the clinic on 5 occasions to receive a single dose of the ivermectin liquid medicines (6 mg) on 3 occasions and the Stromectol® tablet (6 mg) on 2 occasions (5 periods in total). Each subject will be randomly allocated to a treatment sequence to determine the treatment to be dosed in each period. The subjects will enter the clinic on the day before dosing, they will be dosed on Day 1 and will remain in clinic until 24 hours post-dose. The subjects will return to clinic for some additional study procedures at 48 hours post-dose (Day 3) after each period and at 72 hours post-dose (Day 4) after periods 1 to 4. A washout period of at least 14 days (maximum 28 days) will take place between each product administration. An end of study (follow up) visit will take place 72 hours (Day 4) after the subject’s last dose in period 5 to ensure the continued wellbeing of the subjects.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/1442
Date of REC Opinion
15 Sep 2017
REC opinion
Favourable Opinion