Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-932
Brief summary
This study will assess the adverse events, tolerability, and how oral doses of ABBV-932 moves through the body in healthy adult Chinese participants.
Interventions
DRUGABBV-932
Oral Capsule
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) ≥ 18.0 to ≤ 27.9 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. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
Exclusion criteria
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, unexplained syncope, or any uncontrolled medical illness. * History of suicidal ideation within one year prior to study treatment administration as evidenced by answering yes to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts as evidenced by answering yes to any suicidal behavior question (except a yes to the Has subject engaged in non-suicidal self-injurious behavior question) within the last 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-932 | Up to approximately 43 days | Cmax of ABBV-932 |
| Time to Cmax (Tmax) of ABBV-932 | Up to approximately 43 days | Tmax of ABBV-932 |
| Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 | Up to approximately 43 days | Ctrough of ABBV-932 |
| Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932 | Up to approximately 43 days | AUCtau of ABBV-932 |
| Maximum Plasma Concentration (Cmax) of DCAR | Up to approximately 43 days | Cmax of DCAR |
| Time to Cmax (Tmax) of DCAR | Up to approximately 43 days | Tmax of DCAR |
| Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR | Up to approximately 43 days | Ctrough of DCAR |
| Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR) | Up to approximately 43 days | AUCtau of DCAR |
| Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR) | Up to approximately 43 days | Cmax of DDCAR |
| Time to Cmax (Tmax) of DDCAR | Up to approximately 43 days | Tmax of DDCAR |
| Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR | Up to approximately 43 days | Ctrough of DDCAR |
| Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR | Up to approximately 43 days | AUCtau of DDCAR |
| Number of Participants Experiencing Adverse Events | Up to approximately 75 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
China
Outcome results
None listed