Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952467
• Other study ID #: XPF-008-103
• Secondary ID: 2021-000735-32
• Status: Completed
• Phase: Phase 1
• Start date: July 14, 2021
• Est. completion date: October 4, 2021

Study information

• Verified date: January 2022
• Source: Xenon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• 14C-XEN1101
Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Xenon Pharmaceuticals Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From Screening up to Day 57 post-dose
Secondary	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	From Screening up to Day 57 post-dose
Secondary	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	From Screening up to Day 57 post-dose
Secondary	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	From Screening up to Day 57 post-dose
Secondary	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	From Screening up to Day 57 post-dose
Secondary	Mass balance data for 14C-XEN1101 in urine	CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine))	From Screening up to Day 57 post-dose
Secondary	Mass balance data for 14C-XEN1101 in feces	CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces)	From Screening up to Day 57 post-dose
Secondary	Plasma whole blood concentration ratios for total radioactivity	Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points	From Screening up to Day 57 post-dose
Secondary	Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations		From Screening up to Day 57 post-dose