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

• Sponsor: AbbVie (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05738850
• Collaborator: Gedeon Richter Plc. (Industry)
• Enrollment: 84
• Locations: 2
• Arms: 7
• Anticipated Duration (Months): 6.8
• Patients Per Site: 42
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Generalized Anxiety Disorder (GAD); Healthy Participants	Drug: ABBV-932; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects
• Actual Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Sep 10, 2023
• Anticipated Study Completion Date: Sep 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: ABBV-932 Participants will receive ABBV-932 on Day 1 and followed for 30 days.	Drug: ABBV-932; Oral Capsule
Placebo Comparator: Part 1: Placebo Participants will receive placebo on Day 1 and followed for 30 days.	Drug: Placebo; Oral Capsule
Experimental: 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.	Drug: ABBV-932; Oral Capsule
Experimental: 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.	Drug: ABBV-932; Oral Capsule
Experimental: Part 3: Japanese Participants: ABBV-932 Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.	Drug: ABBV-932; Oral Capsule
Placebo Comparator: Part 3: Japanese Participants: Placebo Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.	Drug: Placebo; Oral Capsule
Experimental: Part 3: Han-Chinese Participants: ABBV-932 Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.	Drug: ABBV-932; Oral Capsule

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration (Cmax) of ABBV-932 [Up to approximately 5 days]

   Cmax of ABBV-932.

2. Time to Cmax (Tmax) of ABBV-932 [Up to approximately 5 days]

   Tmax of ABBV-932.

3. Terminal Phase Elimination Rate Constant (Beta) of ABBV-932 [Up to approximately 5 days]

   Terminal phase elimination rate constant (beta) of ABBV-932.

4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 [Up to approximately 5 days]

   Terminal phase elimination half-life of ABBV-932.

5. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 [Up to approximately 5 days]

   AUCt of ABBV-932.

6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 [Up to approximately 5 days]

   AUCinf of ABBV-932.

7. Maximum Plasma Concentration (Cmax) of DCAR [Up to approximately 5 days]

   Cmax of DCAR.

8. Time to Cmax (Tmax) of DCAR [Up to approximately 5 days]

   Tmax of DCAR.

9. Terminal Phase Elimination Rate Constant (Beta) of DCAR [Up to approximately 5 days]

   Terminal phase elimination rate constant (beta) of DCAR.

10. Terminal Phase Elimination Half-Life (t1/2) of DCAR [Up to approximately 5 days]

    Terminal phase elimination half-life of DCAR.

11. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR [Up to approximately 5 days]

    AUCt of DCAR.

12. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR [Up to approximately 5 days]

    AUCinf of DCAR.

13. Maximum Plasma Concentration (Cmax) of DDCAR [Up to approximately 5 days]

    Cmax of DDCAR.

14. Time to Cmax (Tmax) of DDCAR [Up to approximately 5 days]

    Tmax of DDCAR.

15. Terminal Phase Elimination Rate Constant (Beta) of DDCAR [Up to approximately 5 days]

    Terminal phase elimination rate constant (beta) of DDCAR.

16. Terminal Phase Elimination Half-Life (t1/2) of DDCAR [Up to approximately 5 days]

    Terminal phase elimination half-life of DDCAR.

17. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR [Up to approximately 5 days]

    AUCt of DDCAR.

18. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR [Up to approximately 5 days]

    AUCinf of DDCAR.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials LLC /ID# 254178	Anaheim	California	United States	92801-2658
2	Acpru /Id# 249639	Grayslake	Illinois	United States	60030

Sponsors and Collaborators

• AbbVie
• Gedeon Richter Plc.

Investigators

• Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT05738850
• Other Study ID Numbers: M23-889
• First Posted: Feb 22, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by AbbVie: Generalized Anxiety Disorder (GAD); ABBV-932
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Feb 24, 2023