Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants

Healthy Participants Clinical Trial

Official title:

Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05738850
• Other study ID #: M23-889
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 15, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder (GAD)
• Healthy Participants

Intervention

Drug:
• ABBV-932
Oral Capsule
• Placebo
Oral Capsule

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 254178	Anaheim	California
United States	Acpru /Id# 249639	Grayslake	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Gedeon Richter Plc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of ABBV-932	Cmax of ABBV-932.	Up to approximately 5 days
Primary	Time to Cmax (Tmax) of ABBV-932	Tmax of ABBV-932.	Up to approximately 5 days
Primary	Terminal Phase Elimination Rate Constant (Beta) of ABBV-932	Terminal phase elimination rate constant (beta) of ABBV-932.	Up to approximately 5 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-932	Terminal phase elimination half-life of ABBV-932.	Up to approximately 5 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932	AUCt of ABBV-932.	Up to approximately 5 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932	AUCinf of ABBV-932.	Up to approximately 5 days
Primary	Maximum Plasma Concentration (Cmax) of DCAR	Cmax of DCAR.	Up to approximately 5 days
Primary	Time to Cmax (Tmax) of DCAR	Tmax of DCAR.	Up to approximately 5 days
Primary	Terminal Phase Elimination Rate Constant (Beta) of DCAR	Terminal phase elimination rate constant (beta) of DCAR.	Up to approximately 5 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of DCAR	Terminal phase elimination half-life of DCAR.	Up to approximately 5 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR	AUCt of DCAR.	Up to approximately 5 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR	AUCinf of DCAR.	Up to approximately 5 days
Primary	Maximum Plasma Concentration (Cmax) of DDCAR	Cmax of DDCAR.	Up to approximately 5 days
Primary	Time to Cmax (Tmax) of DDCAR	Tmax of DDCAR.	Up to approximately 5 days
Primary	Terminal Phase Elimination Rate Constant (Beta) of DDCAR	Terminal phase elimination rate constant (beta) of DDCAR.	Up to approximately 5 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of DDCAR	Terminal phase elimination half-life of DDCAR.	Up to approximately 5 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR	AUCt of DDCAR.	Up to approximately 5 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR	AUCinf of DDCAR.	Up to approximately 5 days

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