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

X

Xenon Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: 14C-XEN1101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04952467
XPF-008-103
2021-000735-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

6 participants in 1 patient group

Drug: (14C)-XEN1101
Experimental group
Description:
Subjects will receive oral 14C-XEN1101 under fed conditions.
Treatment:
Drug: 14C-XEN1101

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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