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Completed

NCT Number: NCT04952467

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

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.

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14C-XEN1101

Drug

Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101

Primary outcomes

  1. 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

Secondary outcomes

  1. 14C Metabolite profiling in of plasma, urine and feces

    Time frame: From Screening up to Day 57 post-dose

    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

  2. Pharmacokinetic (PK) data for 14C-XEN1101; Tmax

    Time frame: From Screening up to Day 57 post-dose

    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

  3. PK data for 14C-XEN1101; Cmax

    Time frame: From Screening up to Day 57 post-dose

    Maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101

  4. PK data for 14C-XEN1101; T1/2

    Time frame: From Screening up to Day 57 post-dose

    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

  5. Mass balance data for 14C-XEN1101 in urine

    Time frame: From Screening up to Day 57 post-dose

    CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine))

  6. Mass balance data for 14C-XEN1101 in feces

    Time frame: From Screening up to Day 57 post-dose

    CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces)

  7. Plasma whole blood concentration ratios for total radioactivity

    Time frame: From Screening up to Day 57 post-dose

    Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points

  8. 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

Sponsors and collaborators

Lead sponsor

Xenon Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2021
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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