Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-932
Brief summary
The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.
Interventions
DRUGABBV-932
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) ≥ 18.0 to ≤ 29.9.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters. * Male participant who is not considering fathering a child or donating sperm during the study and for 100 days after the study drug administration * A condition of general good health, based upon the results of a medical history, physical exam
Exclusion criteria
* Has not participated in another \[14C\] absorption, distribution, metabolism, excretion (ADME) study with a radiodose above 0.1 MBq in the period of 12 months prior to screening. * Use of any medications/products known to alter drug absorption, metabolism, or excretion processes, within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration. * Prior exposure to ABBV-932 or cariprazine within the past 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-932 | Up to approximately 86 days | Cmax of ABBV-932 |
| Time to Cmax (Tmax) of ABBV-932 | Up to approximately 86 days | Tmax of ABBV-932 |
| Terminal phase elimination rate constant (λz) of ABBV-932 | Up to approximately 86 days | Terminal phase elimination rate constant (λz) of ABBV-932 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 | Up to approximately 86 days | Terminal phase elimination half-life of ABBV-932 |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 | Up to approximately 86 days | AUCt of ABBV-932 |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 | Up to approximately 86 days | AUCinf of ABBV-932 |
| Number of Participants Experiencing Adverse Events | Up to approximately 103 days | An 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. |
Countries
Netherlands
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed