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Completed

NCT Number: NCT06425003

Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration

The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
  • Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.

Exclusion criteria

  • Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  • Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.

Treatment and study plan

[14C] ABBV-CLS-7262

Drug

Oral Solution

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 30 days from last dose.

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  2. Maximum observed concentration (Cmax)

    Time frame: Up to approximately Day 15 from last dose

    Cmax will be assessed.

  3. Time to Cmax (peak time, Tmax)

    Time frame: Up to approximately 15 days from last dose

    Tmax will be assessed.

  4. Terminal phase elimination half-life (t1/2)

    Time frame: Up to approximately 15 days from last dose

    Terminal phase elimination half-life (t1/2) will be assessed.

  5. Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)

    Time frame: Up to approximately 15 days from last dose

    AUCt will be assessed.

  6. Percent radioactivity excreted

    Time frame: Up to approximately 15 days from last dose

    Percentage total radioactivity

  7. Identification of metabolites excreted

    Time frame: Up to approximately 15 days from last dose

    Identification of the major metabolites

Sponsors and collaborators

Lead sponsor

Calico Life Sciences LLC

Industry

Collaborators

  • AbbVie

Registry information

Official study title

Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2024
Registry last updated
Jul 19, 2024

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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