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

NCT02929342 | Completed Phase 1

• 2 other identifiers: P15-02 / Pitolisant2016-000748-32
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (8)

• 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

• Peak Plasma Concentration (Cmax), pitolisant and major metabolites.

  From Day 1 (pre-dose) until 168hours post last dose

• 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

• Volume of distribution (Vz/F), pitolisant and major metabolites.

  From Day 1 (pre-dose) until 168hours post last dose

• Apparent clearance (Clss/F), pitolisant and major metabolites.

  From Day 1 (pre-dose) until 168hours post last dose

• The slope of the apparent elimination phase (lambda-z), pitolisant and major metabolites.

  From Day 1 (pre-dose) until 168hours post last dose

• The apparent elimination half-life (T½), pitolisant and major metabolites.

  From Day 1 (pre-dose) until 168hours post last dose

• Time to reach Cmax (Tmax), pitolisant and major metabolites.

  From Day 1 (pre-dose) until 168hours post last dose

Study Arms (2)

Pitolisant

EXPERIMENTAL

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

Drug: Pitolisant

[14C]-Pitolisant

EXPERIMENTAL

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

Radiation: [14C]-Pitolisant

Interventions

Pitolisant DRUG

Pitolisant

[14C]-Pitolisant RADIATION

[14C]-Pitolisant

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioprojet: lead

MeSH Terms

Interventions

pitolisant

Study Officials

• Litza McKenzie, MD

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

• Thierry Duvauchelle, MD

  Bioprojet Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 11, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-10