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Completed

NCT Number: NCT04070846

Mass Balance Study of [14C]LC350189 in Healthy Volunteers

This is a Phase 1, open-label, single-dose, mass balance study designed to evaluate the absorption, metabolism, and excretion of [14C] radiolabeled LC350189 after oral administration.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject is male 18 to 55 years of age, inclusive.
  • The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
  • The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram results, and physical examination findings at screening.
  • The subject is able to provide written informed consent.

Exclusion criteria

  • The subject has a medical history of any issues affecting absorption or metabolism, as judged by the investigator.
  • The subject has a medical history of any problems affecting venous access or bowel/bladder function.
  • The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
  • The subject has used any prescription or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug.
  • The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or during the study.
  • The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
  • The subject is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or during the study.
  • The subject has donated blood or blood products >450 mL within 30 days before the first dose of study drug.
  • The subject has a history of relevant drug and/or food allergies (ie, allergy to study drug or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).

Treatment and study plan

[14C] LC350189

Drug

Carbon-14 labelded LC350189

Primary outcomes

  1. Mass balance recovery of total radioactivity in whole blood and plasma.

    Time frame: Before dosing on Days 1 through Day 10 (240 hours)

    Radioactivity is measured by radiation dosimetry.

  2. Mass balance recovery of total radioactivity in whole urine, and feces.

    Time frame: Before dosing on Days 1 through Day 10 (240 hours)

    Radioactivity is measured by radiation dosimetry.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: form baseline up to Day 11

    Safety

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single-Dose, Mass Balance Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-LC350189 in Healthy Male Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Jun 26, 2020

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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