Clinical trial NCT04952467: Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: XEN1101
Mass Balance
Phase 1
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-07
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

* 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:

* 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
* 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

Primary outcomes:
measure: Total radioactivity excreted in urine and faeces following oral administration of XEN1101
timeFrame: From Screening up to Day 57 post-dose
Secondary outcomes:
measure: 14C Metabolite profiling in of plasma, urine and feces
timeFrame: From Screening up to Day 57 post-dose
measure: Pharmacokinetic (PK) data for 14C-XEN1101; Tmax
timeFrame: From Screening up to Day 57 post-dose
measure: PK data for 14C-XEN1101; Cmax
timeFrame: From Screening up to Day 57 post-dose
measure: PK data for 14C-XEN1101; T1/2
timeFrame: From Screening up to Day 57 post-dose
measure: Mass balance data for 14C-XEN1101 in urine
timeFrame: From Screening up to Day 57 post-dose
measure: Mass balance data for 14C-XEN1101 in feces
timeFrame: From Screening up to Day 57 post-dose
measure: Plasma whole blood concentration ratios for total radioactivity
timeFrame: From Screening up to Day 57 post-dose
measure: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
timeFrame: From Screening up to Day 57 post-dose
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Xenon Pharmaceuticals Inc.
name: Study Director
role: STUDY_DIRECTOR
References: