HealthyPhase 1NCT03886103
Pharmacokinetics and Metabolism of (14C)-Labelled PXL770
A Phase 1 study testing 14C labeled PXL770 in people with Healthy, run by Poxel SA at 1 site in United Kingdom.
Trial summary
This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects. 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
- What is being tested?
- 14C labeled PXL770
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2019to 15 Mar 2019
- 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 Caucasian males
- Age 30 to 65 years
- BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg.
- Must be willing and able to communicate and participate in the whole study
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
- Must provide written informed consent
- Regular alcohol consumption of 4-14 units of alcohol per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- Must agree to adhere to the contraception
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1
- any drug or alcohol abuse
- Current smokers and those who have smoked within the last 12 months.
- Radiation exposure, including that from the present study, excluding background adiation 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 exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study
- Clinically significant abnormal biochemistry, hematology, coagulation or urinalysis as judged by the investigator
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- Positive test for HIV, HBV, HBC
- eGFR <80 mL/min
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
- Known sensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions)
- History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome
- Mental handicap
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers
This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.
- Conditions
- Healthy
- Being tested
- 14C labeled PXL770
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C labeled PXL770Drug
Single administration
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Experimental | Single of 14C-PXL770 Receives: Drug: 14C labeled PXL770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery
Mass balance recovery of total radioactivity in all excreta: cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Measured: From day 1 to day 7
Secondary outcomes (3)
PK profile of total radioactivity
Cmax
Measured: From day 1 to day 7
PK profile of PXL770
Cmax
Measured: From day 1 to day 7
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events
Measured: From day 1 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start6 Feb 2019
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poxel SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886103
- Sponsor's protocol ID
- PXL770-005
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03886103
- Acronym / sponsor ID
- PXL770-005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- 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.
This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Experimental | Drug: 14C labeled PXL770Single of 14C-PXL770 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy Caucasian males
- Age 30 to 65 years
- BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg.
- Must be willing and able to communicate and participate in the whole study
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (12 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1
- any drug or alcohol abuse
- Current smokers and those who have smoked within the last 12 months.
- Radiation exposure, including that from the present study, excluding background adiation 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 exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study
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 |
|---|---|---|
| 14C labeled PXL770Single administration | Drug | Healthy volunteer |
Primary outcome
Mass balance recovery
Time frame: From day 1 to day 7
Mass balance recovery of total radioactivity in all excreta: cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
3 secondary outcomes
PK profile of total radioactivity
Time frame: From day 1 to day 7
PK profile of PXL770
Time frame: From day 1 to day 7
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From day 1 to day 7
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 22 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C labeled PXL770 in people with Healthy, run by Poxel SA at 1 site in United Kingdom.
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 8 inclusion and 12 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (time frame: From day 1 to day 7). 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 22 Mar 2019.