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Completed

NCT Number: NCT05995366

A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration

The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in healthy male volunteers following a single oral dose administration.

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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. /ID# 253962

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

  • Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at Screening and upon initial confinement.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion criteria

  • History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to study drug administration.
  • Consider fathering a child or donating sperm during the study and for 94 days after study drug administration.
  • 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

ABBV-903

Drug

Solution; Oral

Primary outcomes

  1. Maximum observed concentration (Cmax) of ABBV-903

    Time frame: Up to Day 16

    Cmax of ABBV-903 will be assessed.

  2. Time to Cmax (peak time, Tmax) of ABBV-903

    Time frame: Up to Day 16

    Tmax of ABBV-903 will be assessed.

  3. Terminal Phase Elimination Half-life (t1/2) of ABBV-903

    Time frame: Up to Day 16

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

  4. Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903

    Time frame: Up to Day 16

    AUC0-t of ABBV-903 will be assessed.

  5. AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903

    Time frame: Up to Day 16

    AUC0-inf of ABBV-903 will be assessed.

  6. Number of Participants with Adverse Events (AEs)

    Time frame: Baseline to Day 46

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Mass Balance Study of [14C] ABBV-903 in Healthy Male Subjects Following Single Oral Dose Administration

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2023
Registry last updated
Oct 26, 2023

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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