A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants
- Registration Number
- NCT06953934
- Lead Sponsor
- AbbVie
- Brief Summary
The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABBV-932 ABBV-932 Participants will receive a single oral dose of ABBV-932 on day 1.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method