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

NCT06278766 | Completed Phase 1

• 1 other identifier: M24-416
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-552

Outcome Measures

Primary Outcomes (12)

• Number of Participants with Adverse Events (AEs)

  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

  Cmax of ABBV-552 will be assessed.

  Up to approximately Day 15

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

  Tmax of ABBV-552 will be assessed.

  Up to approximately 15 days

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

  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

  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

  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

  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)

  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

  Percent excreted = 100 × (Aeu/dose).

  Up to approximately 15 days

• Renal clearance ABBV-552 (CLr)

  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)

  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

  Percent excreted = 100 × (Aef/dose).

  Up to approximately 15 days

Study Arms (1)

ABBV-552

EXPERIMENTAL

Participants will receive ABBV-552 on Day 1.

Drug: ABBV-552

Interventions

ABBV-552 DRUG

Oral Solution

ABBV-552

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Male volunteers in general good health at Screening.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc /ID# 262684

Madison, Wisconsin, 53704, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 26, 2024
• Study Start: February 21, 2024
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)