ADME study of Pitolisant in Healthy CYP2D6 Genotyped Males (QCL117662)
Research type
Research Study
Full title
An Open Label, Single-Period Repeated Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Pitolisant, at Steady-State Conditions, in Healthy CYP2D6 Genotyped Male Subjects
IRAS ID
206838
Contact name
Stephane Piris
Sponsor organisation
Bioprojet Pharma
Eudract number
2016-000748-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
The Sponsor is developing the study drug, Pitolisant, for the treatment of narcolepsy (inability to regulate wake-sleep cycles). It may also be useful for the treatment of excessive daytime sleepiness that occurs in conditions such as obstructive sleep apnoea (OSA) and Parkinson's disease.
The purpose of the study is to measure how the study drug, Pitolisant, is taken up, broken down and removed by the body when given at steady state in CYP2D6 genotyped subjects. As a condition of recommending a marketing authorisation for Pitolisant for the treatment of narcolepsy, the European Medicines Agency Committee for Medicinal Products for Human Use have requested that further study is made of the pharmacokinetics and metabolism at steady state and in people who may not metabolise the drug as fast as most of the population (i.e. CYP2D6 poor metabolisers). This absorption, distribution, metabolism and excretion (ADME) study is to be conducted to contribute to the fulfilment of those requirements.
Nine male subjects will be enrolled and will receive a single daily dose of the study drug from day 1 until day 7. On day 8 subjects will be administered with the study drug containing a small amount of radioactivity. Subjects will remain in the clinic for 7 days after the day 8 administration. If by this stage, enough of the radioactive dose has not been recovered from the urine, faeces and expired air of all volunteers by Day 15, home collections of urine and faeces may be requested at the discretion of the investigator, scientific lead and sponsor for individual subjects.
REC name
HSC REC B
REC reference
16/NI/0095
Date of REC Opinion
14 Jun 2016
REC opinion
Favourable Opinion