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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929342
• Other study ID #: P15-02 / Pitolisant
• Secondary ID: 2016-000748-32
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2016
• Last updated: October 7, 2016
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Pitolisant

Radiation:
• [14C]-Pitolisant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance recovery of total radioactivity (Ae) in urine, faeces and expired air.		from Day 8 (pre-dose) to 120 h post 14C-radioactivity dose	No
Primary	Peak Plasma Concentration (Cmax), pitolisant and major metabolites.		From Day 1 (pre-dose) until 168hours post last dose	No
Primary	Area under the plasma concentration versus time curve [AUC(0-tau), AUC(0-inf), %AUCextrap], pitolisant and major metabolites.		From Day 1 (pre-dose) until 168hours post last dose	No
Primary	Volume of distribution (Vz/F), pitolisant and major metabolites.		From Day 1 (pre-dose) until 168hours post last dose	No
Primary	Apparent clearance (Clss/F), pitolisant and major metabolites.		From Day 1 (pre-dose) until 168hours post last dose	No
Primary	The slope of the apparent elimination phase (lambda-z), pitolisant and major metabolites.		From Day 1 (pre-dose) until 168hours post last dose	No
Primary	The apparent elimination half-life (T½), pitolisant and major metabolites.		From Day 1 (pre-dose) until 168hours post last dose	No
Primary	Time to reach Cmax (Tmax), pitolisant and major metabolites.		From Day 1 (pre-dose) until 168hours post last dose	No