Generalized Anxiety Disorder (GAD)Phase 1NCT05738850
Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants
A Phase 1 study testing ABBV-932 in people with Generalized Anxiety Disorder (GAD) and Healthy Participants, run by AbbVie at 2 sites in United States.
Trial summary
The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Healthy Participants
- What is being tested?
- ABBV-932
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Feb 2023to 31 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials LLC /ID# 254178
Anaheim, California, 92801-2658
Acpru /Id# 249639
Grayslake, Illinois, 60030
About this study
Official title: Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects
The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.
- Being tested
- ABBV-932, Placebo
- Keywords
- Generalized Anxiety Disorder (GAD), ABBV-932
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-932Drug
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ABBV-932 | Experimental | Participants will receive ABBV-932 on Day 1 and followed for 30 days. Receives: Drug: ABBV-932 |
| Part 1: Placebo | Placebo comparator | Participants will receive placebo on Day 1 and followed for 30 days. Receives: Drug: Placebo |
| Part 2: Sequence 1 | Experimental | 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. Receives: Drug: ABBV-932 |
| Part 2: Sequence 2 | Experimental | 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. Receives: Drug: ABBV-932 |
| Part 3: Japanese Participants: ABBV-932 | Experimental | Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days. Receives: Drug: ABBV-932 |
| Part 3: Japanese Participants: Placebo | Placebo comparator | Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. Receives: Drug: Placebo |
| Part 3: Han-Chinese Participants: ABBV-932 | Experimental | Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. Receives: Drug: ABBV-932 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of ABBV-932
Cmax of ABBV-932.
Measured: Up to approximately 5 days
Time to Cmax (Tmax) of ABBV-932
Tmax of ABBV-932.
Measured: Up to approximately 5 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
Terminal phase elimination rate constant (beta) of ABBV-932.
Measured: Up to approximately 5 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Terminal phase elimination half-life of ABBV-932.
Measured: Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
AUCt of ABBV-932.
Measured: Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
AUCinf of ABBV-932.
Measured: Up to approximately 5 days
Maximum Plasma Concentration (Cmax) of DCAR
Cmax of DCAR.
Measured: Up to approximately 5 days
Time to Cmax (Tmax) of DCAR
Tmax of DCAR.
Measured: Up to approximately 5 days
Terminal Phase Elimination Rate Constant (Beta) of DCAR
Terminal phase elimination rate constant (beta) of DCAR.
Measured: Up to approximately 5 days
Terminal Phase Elimination Half-Life (t1/2) of DCAR
Terminal phase elimination half-life of DCAR.
Measured: Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR
AUCt of DCAR.
Measured: Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR
AUCinf of DCAR.
Measured: Up to approximately 5 days
Maximum Plasma Concentration (Cmax) of DDCAR
Cmax of DDCAR.
Measured: Up to approximately 5 days
Time to Cmax (Tmax) of DDCAR
Tmax of DDCAR.
Measured: Up to approximately 5 days
Terminal Phase Elimination Rate Constant (Beta) of DDCAR
Terminal phase elimination rate constant (beta) of DDCAR.
Measured: Up to approximately 5 days
Terminal Phase Elimination Half-Life (t1/2) of DDCAR
Terminal phase elimination half-life of DDCAR.
Measured: Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR
AUCt of DDCAR.
Measured: Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
AUCinf of DDCAR.
Measured: Up to approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start15 Feb 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Plc.
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738850
- Sponsor's protocol ID
- M23-889
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05738850
- Acronym / sponsor ID
- M23-889
- Keywords
- Generalized Anxiety Disorder (GAD), ABBV-932
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Plc.
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: ABBV-932 | Experimental | Drug: ABBV-932Participants will receive ABBV-932 on Day 1 and followed for 30 days. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo on Day 1 and followed for 30 days. |
| Part 2: Sequence 1 | Experimental | Drug: ABBV-932Participants 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. |
| Part 2: Sequence 2 | Experimental | Drug: ABBV-932Participants 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. |
| Part 3: Japanese Participants: ABBV-932 | Experimental | Drug: ABBV-932Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days. |
| Part 3: Japanese Participants: Placebo | Placebo comparator | Drug: PlaceboJapanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
| Part 3: Han-Chinese Participants: ABBV-932 | Experimental | Drug: ABBV-932Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-932Oral Capsule | Drug | Part 1: ABBV-932, Part 2: Sequence 1, Part 2: Sequence 2, Part 3: Han-Chinese Participants: ABBV-932, Part 3: Japanese Participants: ABBV-932 |
| PlaceboOral Capsule | Drug | Part 1: Placebo, Part 3: Japanese Participants: Placebo |
Primary outcome
Maximum Plasma Concentration (Cmax) of ABBV-932
Time frame: Up to approximately 5 days
Cmax of ABBV-932.
Time to Cmax (Tmax) of ABBV-932
Time frame: Up to approximately 5 days
Tmax of ABBV-932.
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.
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.
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 Infinity (AUCinf) of ABBV-932
Time frame: Up to approximately 5 days
AUCinf of ABBV-932.
Maximum Plasma Concentration (Cmax) of DCAR
Time frame: Up to approximately 5 days
Cmax of DCAR.
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.
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 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.
Maximum Plasma Concentration (Cmax) of DDCAR
Time frame: Up to approximately 5 days
Cmax of DDCAR.
Time to Cmax (Tmax) of DDCAR
Time frame: Up to approximately 5 days
Tmax 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.
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.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
Time frame: Up to approximately 5 days
AUCinf of DDCAR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-932 in people with Generalized Anxiety Disorder (GAD) and Healthy Participants, run by AbbVie at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of ABBV-932 (time frame: Up to approximately 5 days). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.