Clinical trial NCT05738850: Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants
Official title: Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Generalized Anxiety Disorder (GAD)
Healthy Participants
Keywords: Generalized Anxiety Disorder (GAD)
ABBV-932
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Plc.
First posted: 2023-02-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Parts 1 and 2: Healthy individuals with body-mass index (BMI) \>= 18.0 to \<= 32.0 kg/m2, rounded to the tenths decimal.
* Part 3: Healthy Japanese, Han Chinese individuals with BMI \>= 18.0 to \<= 30.0 kg/m2, rounded to the tenths decimal.
* Condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead ECG.

Exclusion Criteria:

- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of ABBV-932
timeFrame: Up to approximately 5 days
measure: Time to Cmax (Tmax) of ABBV-932
timeFrame: Up to approximately 5 days
measure: Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
timeFrame: Up to approximately 5 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
timeFrame: Up to approximately 5 days
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
timeFrame: Up to approximately 5 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
timeFrame: Up to approximately 5 days
measure: Maximum Plasma Concentration (Cmax) of DCAR
timeFrame: Up to approximately 5 days
measure: Time to Cmax (Tmax) of DCAR
timeFrame: Up to approximately 5 days
measure: Terminal Phase Elimination Rate Constant (Beta) of DCAR
timeFrame: Up to approximately 5 days
measure: Terminal Phase Elimination Half-Life (t1/2) of DCAR
timeFrame: Up to approximately 5 days
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR
timeFrame: Up to approximately 5 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR
timeFrame: Up to approximately 5 days
measure: Maximum Plasma Concentration (Cmax) of DDCAR
timeFrame: Up to approximately 5 days
measure: Time to Cmax (Tmax) of DDCAR
timeFrame: Up to approximately 5 days
measure: Terminal Phase Elimination Rate Constant (Beta) of DDCAR
timeFrame: Up to approximately 5 days
measure: Terminal Phase Elimination Half-Life (t1/2) of DDCAR
timeFrame: Up to approximately 5 days
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR
timeFrame: Up to approximately 5 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
timeFrame: Up to approximately 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 254178
state: California
city: Grayslake
country: United States
facility: Acpru /Id# 249639
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: