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A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration - Trial NCT06278766

Access comprehensive clinical trial information for NCT06278766 through Pure Global AI's free database. This Phase 1 trial is sponsored by AbbVie and is currently Recruiting. The study focuses on Healthy Volunteer. Target enrollment is 8 participants.

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NCT06278766
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06278766
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A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration
Mass Balance Study of [14C] ABBV-552 in Healthy Male Volunteers Following Single Oral Dose Administration

Study Focus

Healthy Volunteer

ABBV-552

Interventional

drug

Sponsor & Location

AbbVie

Madison, United States of America

Timeline & Enrollment

Phase 1

Feb 21, 2024

Apr 19, 2024

8 participants

Primary Outcome

Number of Participants with Adverse Events (AEs),Maximum observed concentration (Cmax) of ABBV-552,Time to Cmax (peak time, Tmax) of ABBV-552,Terminal phase elimination rate constant (ฮปz) of ABBV-552,Terminal phase elimination half-life (t1/2) of ABBV-552,Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552,Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552,Amount of ABBV-552 excreted in the urine over the sampling period (Aeu),Percent of ABBV-552 excreted in the urine,Renal clearance ABBV-552 (CLr),Amount of ABBV-552 excreted in the feces over the sampling period (Aef),Percent radioactivity excreted in the feces

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.

ICD-10 Classifications

Healthy person accompanying sick person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06278766

Non-Device Trial