Healthy VolunteersPhase 1NCT02929342
Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers
A Phase 1 study testing Pitolisant and [14C]-Pitolisant in people with Healthy Volunteers, run by Bioprojet.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Pitolisant and [14C]-Pitolisant
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males aged 30 to 65 years.
- Body mass index 18.0 to 35.0 kg/m2.
- Genotyped with regard to their CYP2D6 status.
Who cannot join
- 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
About this study
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
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
- Being tested
- Pitolisant, [14C]-Pitolisant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitolisantDrug
[14C]-PitolisantRadiation
| Study group | Role | What they receive |
|---|---|---|
| Pitolisant | Experimental | Pitolisant, oral single dose administration, from Day1 to Day7. Receives: Drug: Pitolisant |
| [14C]-Pitolisant | Experimental | [14C]-Pitolisant, oral single dose administration at Day8. Receives: Radiation: [14C]-Pitolisant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity (Ae) in urine, faeces and expired air.
Measured: from Day 8 (pre-dose) to 120 h post 14C-radioactivity dose
Peak Plasma Concentration (Cmax), pitolisant and major metabolites.
Measured: 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.
Measured: From Day 1 (pre-dose) until 168hours post last dose
Volume of distribution (Vz/F), pitolisant and major metabolites.
Measured: From Day 1 (pre-dose) until 168hours post last dose
Apparent clearance (Clss/F), pitolisant and major metabolites.
Measured: From Day 1 (pre-dose) until 168hours post last dose
The slope of the apparent elimination phase (lambda-z), pitolisant and major metabolites.
Measured: From Day 1 (pre-dose) until 168hours post last dose
The apparent elimination half-life (T½), pitolisant and major metabolites.
Measured: From Day 1 (pre-dose) until 168hours post last dose
Time to reach Cmax (Tmax), pitolisant and major metabolites.
Measured: From Day 1 (pre-dose) until 168hours post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Litza McKenzie, MD, Principal investigator, Quotient ClinicalThierry Duvauchelle, MD, Study director, Bioprojet Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929342
- Sponsor's protocol ID
- P15-02 / Pitolisant
- Other IDs
- 2016-000748-32, 2016
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02929342
- Acronym / sponsor ID
- P15-02 / Pitolisant
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitolisant | Experimental | Drug: PitolisantPitolisant, oral single dose administration, from Day1 to Day7. |
| [14C]-Pitolisant | Experimental | Radiation: [14C]-Pitolisant[14C]-Pitolisant, oral single dose administration at Day8. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males aged 30 to 65 years.
- Body mass index 18.0 to 35.0 kg/m2.
- Genotyped with regard to their CYP2D6 status.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitolisant | Drug | Pitolisant |
| [14C]-Pitolisant | Radiation | [14C]-Pitolisant |
Primary outcome
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
Peak Plasma Concentration (Cmax), pitolisant and major metabolites.
Time frame: 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.
Time frame: From Day 1 (pre-dose) until 168hours post last dose
Volume of distribution (Vz/F), pitolisant and major metabolites.
Time frame: From Day 1 (pre-dose) until 168hours post last dose
Apparent clearance (Clss/F), pitolisant and major metabolites.
Time frame: From Day 1 (pre-dose) until 168hours post last dose
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
The apparent elimination half-life (T½), pitolisant and major metabolites.
Time frame: From Day 1 (pre-dose) until 168hours post last dose
Time to reach Cmax (Tmax), pitolisant and major metabolites.
Time frame: From Day 1 (pre-dose) until 168hours post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Litza McKenzie, MD principal investigator
Quotient Clinical
Thierry Duvauchelle, MD study director
Bioprojet Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pitolisant and [14C]-Pitolisant in people with Healthy Volunteers, run by Bioprojet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.