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Unknown

ABBV-932 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parts 1 and 2: Healthy individuals with body-mass index (BMI) >= 18.0 to <= 32.0 kg/m2, rounded to the tenths decimal.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 days
Awards & highlights

Study Summary

This trial looks at how safe and effective a new drug is in healthy adults.

Who is the study for?
This trial is for healthy adults, including Japanese and Han Chinese individuals with a BMI between 18.0 to 32.0 kg/m2. Participants must be in good health based on medical history, physical exams, lab tests, neurological exams, and ECG results. Those who've had significant illness or surgery within the last 30 days cannot join.Check my eligibility
What is being tested?
The study is testing ABBV-932 oral capsules to see how they're processed by the body (pharmacokinetics) and to check their safety and tolerability compared to a placebo (a pill without active medication).See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions that may arise from taking ABBV-932 as it's being tested for safety and tolerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am healthy with a BMI between 18.0 and 32.0.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
+15 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3: Japanese Participants: ABBV-932Experimental Treatment1 Intervention
Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.
Group II: Part 3: Han-Chinese Participants: ABBV-932Experimental Treatment1 Intervention
Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Group III: Part 2: Sequence 2Experimental Treatment1 Intervention
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.
Group IV: Part 2: Sequence 1Experimental Treatment1 Intervention
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.
Group V: Part 1: ABBV-932Experimental Treatment1 Intervention
Participants will receive ABBV-932 on Day 1 and followed for 30 days.
Group VI: Part 3: Japanese Participants: PlaceboPlacebo Group1 Intervention
Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Group VII: Part 1: PlaceboPlacebo Group1 Intervention
Participants will receive placebo on Day 1 and followed for 30 days.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,311 Total Patients Enrolled
2 Trials studying Generalized Anxiety Disorder
64 Patients Enrolled for Generalized Anxiety Disorder
Gedeon Richter Plc.Industry Sponsor
11 Previous Clinical Trials
3,709 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,025 Total Patients Enrolled
1 Trials studying Generalized Anxiety Disorder
64 Patients Enrolled for Generalized Anxiety Disorder

Media Library

ABBV-932 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05738850 — Phase 1
Generalized Anxiety Disorder Research Study Groups: Part 3: Japanese Participants: ABBV-932, Part 3: Han-Chinese Participants: ABBV-932, Part 3: Japanese Participants: Placebo, Part 2: Sequence 1, Part 2: Sequence 2, Part 1: ABBV-932, Part 1: Placebo
Generalized Anxiety Disorder Clinical Trial 2023: ABBV-932 Highlights & Side Effects. Trial Name: NCT05738850 — Phase 1
ABBV-932 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05738850 — Phase 1
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05738850 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment include individuals aged twenty or older?

"This trial is only open to those between 18 and 65 years old. Alternatively, there are 152 studies available for minors or 636 clinical trials designed with seniors in mind."

Answered by AI

Is this experiment currently seeking participants?

"Indeed, the information available on clinicaltrials.gov reveals that recruitment is ongoing for this medical experiment which was initially announced on February 15th 2023 and edited as recently as February 23rd 2023."

Answered by AI

What have been the adverse effects reported from using ABBV-932 during Part 1 of the trial?

"Our researchers at Power have assigned ABBV-932 a 1, as this is only in the initial Phase 1 of clinical trials. Therefore, there exists a dearth of evidence regarding its efficacy and safety profile."

Answered by AI

How many individuals are enrolled in this investigation?

"Affirmative. The data found on clinicaltrials.gov shows that the trial, which was initially listed on February 15th 2023 is currently searching for participants. 84 people are required at two medical centres to complete this study."

Answered by AI

What are the prerequisites for volunteers to qualify for this research?

"This clinical trial is accepting 84 individuals aged 18-65 suffering from generalised anxiety disorder. To be accepted, one must have a BMI of 18.0 - 32.0 kg/m2 for Part 1 and 2 or 18.0 - 30.0 kg/m2 for Japanese & Han Chinese participants in Part 3, as well as indicate that they are generally healthy based on the results of medical history assessments, physical examinations, neurological examinations, ECGs and laboratory profiles."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Anaheim Clinical Trials LLC /ID# 254178
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m a healthy man.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants
2023. "Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05738850.
~6 spots leftby Jun 2024
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