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Completed

NCT Number: NCT06278766

A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration

The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-552 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 /ID# 262684

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

  • Male volunteers in general good health at Screening.

Exclusion criteria

  • Considering fathering a child or donating sperm during the study and for 100 days after study drug administration.

Treatment and study plan

ABBV-552

Drug

Oral Solution

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 30 days

    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) of ABBV-552

    Time frame: Up to approximately Day 15

    Cmax of ABBV-552 will be assessed.

  3. Time to Cmax (peak time, Tmax) of ABBV-552

    Time frame: Up to approximately 15 days

    Tmax of ABBV-552 will be assessed.

  4. Terminal phase elimination rate constant (λz) of ABBV-552

    Time frame: Up to approximately 15 days

    Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed.

  5. Terminal phase elimination half-life (t1/2) of ABBV-552

    Time frame: Up to approximately 15 days

    Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed.

  6. Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552

    Time frame: Up to approximately 15 days

    AUCt of ABBV-552 will be assessed.

  7. Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552

    Time frame: Up to approximately 15 days

    AUCinf of ABBV-552 will be assessed.

  8. Amount of ABBV-552 excreted in the urine over the sampling period (Aeu)

    Time frame: Up to approximately 15 days

    Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed.

  9. Percent of ABBV-552 excreted in the urine

    Time frame: Up to approximately 15 days

    Percent excreted = 100 × (Aeu/dose).

  10. Renal clearance ABBV-552 (CLr)

    Time frame: Up to approximately 15 days

    Renal clearance of ABBV-552 will be assessed.

  11. Amount of ABBV-552 excreted in the feces over the sampling period (Aef)

    Time frame: Up to approximately 15 days

    Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed.

  12. Percent radioactivity excreted in the feces

    Time frame: Up to approximately 15 days

    Percent excreted = 100 × (Aef/dose).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Mass Balance Study of [14C] ABBV-552 in Healthy Male Volunteers Following Single Oral Dose Administration

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Apr 29, 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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