Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers

NCT ID: NCT02929342

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of this study is to better define the absorption and elimination pathways, and circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in healthy CYP2D6 genotyped male subject.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pitolisant

Pitolisant, oral single dose administration, from Day1 to Day7.

Group Type: EXPERIMENTAL

Pitolisant

Intervention Type: DRUG

[14C]-Pitolisant

\[14C\]-Pitolisant, oral single dose administration at Day8.

Group Type: EXPERIMENTAL

[14C]-Pitolisant

Intervention Type: RADIATION

Interventions

Pitolisant

Intervention Type: DRUG

[14C]-Pitolisant

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Healthy males aged 30 to 65 years.
• Body mass index 18.0 to 35.0 kg/m2.
• Genotyped with regard to their CYP2D6 status.

Exclusion Criteria

• Participation in a clinical research study within the previous 3 months
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
• Regular alcohol consumption in males >21 units per week.
• Current smokers and those who have smoked within the last 12 months.
• Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation.
• Use of CYP2D6 inhibitors or inducers in the 28 days prior to IMP administration

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bioprojet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Litza McKenzie, MD

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical

Thierry Duvauchelle, MD

Role: STUDY_DIRECTOR

Bioprojet Pharma

Other Identifiers

2016-000748-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P15-02 / Pitolisant

Identifier Type: -

Identifier Source: org_study_id