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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06278766
• Other study ID #: M24-416
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2024
• Est. completion date: April 19, 2024

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 19, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ABBV-552
Oral Solution

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit Inc /ID# 262684	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum observed concentration (Cmax) of ABBV-552	Cmax of ABBV-552 will be assessed.	Up to approximately Day 15
Primary	Time to Cmax (peak time, Tmax) of ABBV-552	Tmax of ABBV-552 will be assessed.	Up to approximately 15 days
Primary	Terminal phase elimination rate constant (?z) of ABBV-552	Terminal phase elimination rate constant (?z) of ABBV-552 will be assessed.	Up to approximately 15 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Percent of ABBV-552 excreted in the urine	Percent excreted = 100 × (Aeu/dose).	Up to approximately 15 days
Primary	Renal clearance ABBV-552 (CLr)	Renal clearance of ABBV-552 will be assessed.	Up to approximately 15 days
Primary	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
Primary	Percent radioactivity excreted in the feces	Percent excreted = 100 × (Aef/dose).	Up to approximately 15 days

External Links

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