Healthy VolunteersPhase 1NCT04952467
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
A Phase 1 study testing 14C-XEN1101 in people with Healthy Volunteers, run by Xenon Pharmaceuticals Inc. at 1 site in United Kingdom.
Trial summary
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult 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 Volunteers
- What is being tested?
- 14C-XEN1101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2021to 4 Oct 2021
- 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
- Body mass index (BMI) of 18.0 to 32.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Provide written informed consent
- Adhere to the specified contraception requirements
Who cannot join
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days
- Evidence of any current infection or an infection within 14 days before study drug administration
- History of any drug or alcohol abuse in the past 2 years
- Subjects with pregnant or lactating partners
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (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 2017, shall participate in the study
- Participation in a clinical trial involving administration of radiolabelled compound(s) within 180 days of the planned dosing date of this study
Show all 11Show fewer
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis. Subjects with Gilbert's Syndrome will be excluded.
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: An Open Label, Single-dose, Single-period Study to Assess the Pharmacokinetics, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-XEN1101 in Healthy Male Subjects
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.
- Conditions
- Healthy Volunteers
- Being tested
- 14C-XEN1101
- Keywords
- XEN1101, Mass Balance, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-XEN1101Drug
Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101
| Study group | Role | What they receive |
|---|---|---|
| Drug: (14C)-XEN1101 | Experimental | Subjects will receive oral 14C-XEN1101 under fed conditions. Receives: Drug: 14C-XEN1101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity excreted in urine and faeces following oral administration of XEN1101
Cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and expressed as a % of the radioactive dose administered (Cum%Ae(total)) following oral administration of 14C-XEN1101
Measured: From Screening up to Day 57 post-dose
Secondary outcomes (8)
14C Metabolite profiling in of plasma, urine and feces
Chemical structure of each metabolite classified as >10% (by AUC) of total radioactivity in plasma and >10% dose excreted in urine and faeces following oral administration of XEN1101
Measured: From Screening up to Day 57 post-dose
Pharmacokinetic (PK) data for 14C-XEN1101; Tmax
Time of maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Measured: From Screening up to Day 57 post-dose
PK data for 14C-XEN1101; Cmax
Maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Measured: From Screening up to Day 57 post-dose
PK data for 14C-XEN1101; T1/2
Terminal elimination half-life for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Measured: From Screening up to Day 57 post-dose
Mass balance data for 14C-XEN1101 in urine
CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine))
Measured: From Screening up to Day 57 post-dose
Mass balance data for 14C-XEN1101 in feces
CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces)
Measured: From Screening up to Day 57 post-dose
Plasma whole blood concentration ratios for total radioactivity
Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points
Measured: From Screening up to Day 57 post-dose
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
Measured: From Screening up to Day 57 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start14 Jul 2021
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Xenon Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952467
- Sponsor's protocol ID
- XPF-008-103
- Other IDs
- 2021-000735-32
- Status last verified
- Jan 2022
- First submitted
- 27 Jun 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-dose, Single-period Study to Assess the Pharmacokinetics, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-XEN1101 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04952467
- Acronym / sponsor ID
- XPF-008-103
- Conditions
- Healthy Volunteers
- Keywords
- XEN1101, Mass Balance, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 7 Jul 2021 (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 study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: (14C)-XEN1101 | Experimental | Drug: 14C-XEN1101Subjects will receive oral 14C-XEN1101 under fed conditions. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) of 18.0 to 32.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Provide written informed consent
- Adhere to the specified contraception requirements
Key exclusion criteria (11 listed)
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days
- Evidence of any current infection or an infection within 14 days before study drug administration
- History of any drug or alcohol abuse in the past 2 years
- Subjects with pregnant or lactating partners
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (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 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-XEN1101Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101 | Drug | Drug: (14C)-XEN1101 |
Primary outcome
Total radioactivity excreted in urine and faeces following oral administration of XEN1101
Time frame: From Screening up to Day 57 post-dose
Cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and expressed as a % of the radioactive dose administered (Cum%Ae(total)) following oral administration of 14C-XEN1101
8 secondary outcomes
14C Metabolite profiling in of plasma, urine and feces
Time frame: From Screening up to Day 57 post-dose
Pharmacokinetic (PK) data for 14C-XEN1101; Tmax
Time frame: From Screening up to Day 57 post-dose
PK data for 14C-XEN1101; Cmax
Time frame: From Screening up to Day 57 post-dose
PK data for 14C-XEN1101; T1/2
Time frame: From Screening up to Day 57 post-dose
Mass balance data for 14C-XEN1101 in urine
Time frame: From Screening up to Day 57 post-dose
Mass balance data for 14C-XEN1101 in feces
Time frame: From Screening up to Day 57 post-dose
Plasma whole blood concentration ratios for total radioactivity
Time frame: From Screening up to Day 57 post-dose
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
Time frame: From Screening up to Day 57 post-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 14 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Xenon Pharmaceuticals Inc.
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-XEN1101 in people with Healthy Volunteers, run by Xenon Pharmaceuticals Inc. 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 4 inclusion and 11 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 14 Jan 2022. 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?
Total radioactivity excreted in urine and faeces following oral administration of XEN1101 (time frame: From Screening up to Day 57 post-dose). 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 14 Jan 2022.