Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Time to Cmax (Tmax) of ABBV-932
Study Overview
Brief Summary
The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Part 1: Placebo
Participants will receive placebo on Day 1 and followed for 30 days.
Intervention: Placebo (Drug)
Part 1: ABBV-932
Participants will receive ABBV-932 on Day 1 and followed for 30 days.
Intervention: ABBV-932 (Drug)
Part 2: Sequence 1
Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days.
Intervention: ABBV-932 (Drug)
Part 2: Sequence 2
Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days.
Intervention: ABBV-932 (Drug)
Part 3: Japanese Participants: ABBV-932
Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.
Intervention: ABBV-932 (Drug)
Part 3: Japanese Participants: Placebo
Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Intervention: Placebo (Drug)
Part 3: Han-Chinese Participants: ABBV-932
Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Intervention: ABBV-932 (Drug)
Outcomes
Primary Outcomes
Time to Cmax (Tmax) of ABBV-932
Time Frame: Up to approximately 5 days
Tmax of ABBV-932.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
Time Frame: Up to approximately 5 days
AUCinf of ABBV-932.
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
Time Frame: Up to approximately 5 days
AUCt of ABBV-932.
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR
Time Frame: Up to approximately 5 days
AUCt of DCAR.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR
Time Frame: Up to approximately 5 days
AUCinf of DCAR.
Time to Cmax (Tmax) of DDCAR
Time Frame: Up to approximately 5 days
Tmax of DDCAR.
Maximum Plasma Concentration (Cmax) of ABBV-932
Time Frame: Up to approximately 5 days
Cmax of ABBV-932.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Time Frame: Up to approximately 5 days
Terminal phase elimination half-life of ABBV-932.
Terminal Phase Elimination Half-Life (t1/2) of DCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination half-life of DCAR.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
Time Frame: Up to approximately 5 days
AUCinf of DDCAR.
Maximum Plasma Concentration (Cmax) of DCAR
Time Frame: Up to approximately 5 days
Cmax of DCAR.
Maximum Plasma Concentration (Cmax) of DDCAR
Time Frame: Up to approximately 5 days
Cmax of DDCAR.
Terminal Phase Elimination Rate Constant (Beta) of DDCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination rate constant (beta) of DDCAR.
Terminal Phase Elimination Half-Life (t1/2) of DDCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination half-life of DDCAR.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
Time Frame: Up to approximately 5 days
Terminal phase elimination rate constant (beta) of ABBV-932.
Time to Cmax (Tmax) of DCAR
Time Frame: Up to approximately 5 days
Tmax of DCAR.
Terminal Phase Elimination Rate Constant (Beta) of DCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination rate constant (beta) of DCAR.
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR
Time Frame: Up to approximately 5 days
AUCt of DDCAR.
Secondary Outcomes
No secondary outcomes reported