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Completed

NCT Number: NCT02929342

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitolisant

Drug

[14C]-Pitolisant

Radiation

Primary outcomes

  1. Mass balance recovery of total radioactivity (Ae) in urine, faeces and expired air.

    Time frame: from Day 8 (pre-dose) to 120 h post 14C-radioactivity dose

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

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

  3. Area under the plasma concentration versus time curve [AUC(0-tau), AUC(0-inf), %AUCextrap], pitolisant and major metabolites.

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

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

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

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

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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