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

April 17, 2024 updated by: AbbVie

Mass Balance Study of [14C] ABBV-552 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-552 in healthy, male volunteers following administration of a single oral dose.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Fortrea Clinical Research Unit Inc /ID# 262684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-552
Participants will receive ABBV-552 on Day 1.
Drug: ABBV-552
Oral Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 30 days
Maximum observed concentration (Cmax) of ABBV-552
Time Frame: Up to approximately Day 15
Cmax of ABBV-552 will be assessed.
Up to approximately Day 15
Time to Cmax (peak time, Tmax) of ABBV-552
Time Frame: Up to approximately 15 days
Tmax of ABBV-552 will be assessed.
Up to approximately 15 days
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.
Up to approximately 15 days
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.
Up to approximately 15 days
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.
Up to approximately 15 days
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.
Up to approximately 15 days
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.
Up to approximately 15 days
Percent of ABBV-552 excreted in the urine
Time Frame: Up to approximately 15 days
Percent excreted = 100 × (Aeu/dose).
Up to approximately 15 days
Renal clearance ABBV-552 (CLr)
Time Frame: Up to approximately 15 days
Renal clearance of ABBV-552 will be assessed.
Up to approximately 15 days
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.
Up to approximately 15 days
Percent radioactivity excreted in the feces
Time Frame: Up to approximately 15 days
Percent excreted = 100 × (Aef/dose).
Up to approximately 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Estimated)

April 19, 2024

Study Completion (Estimated)

April 19, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M24-416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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