Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-552
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.
Interventions
DRUGABBV-552
Oral Solution
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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. |
| Maximum observed concentration (Cmax) of ABBV-552 | Up to approximately Day 15 | Cmax of ABBV-552 will be assessed. |
| Time to Cmax (peak time, Tmax) of ABBV-552 | Up to approximately 15 days | Tmax of ABBV-552 will be assessed. |
| Terminal phase elimination rate constant (λz) of ABBV-552 | Up to approximately 15 days | Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed. |
| Terminal phase elimination half-life (t1/2) of ABBV-552 | Up to approximately 15 days | Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed. |
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552 | Up to approximately 15 days | AUCt of ABBV-552 will be assessed. |
| Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552 | Up to approximately 15 days | AUCinf of ABBV-552 will be assessed. |
| Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) | Up to approximately 15 days | Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed. |
| Percent of ABBV-552 excreted in the urine | Up to approximately 15 days | Percent excreted = 100 × (Aeu/dose). |
| Renal clearance ABBV-552 (CLr) | Up to approximately 15 days | Renal clearance of ABBV-552 will be assessed. |
| Amount of ABBV-552 excreted in the feces over the sampling period (Aef) | Up to approximately 15 days | Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed. |
| Percent radioactivity excreted in the feces | Up to approximately 15 days | Percent excreted = 100 × (Aef/dose). |
Countries
United States
Outcome results
None listed