## Protocol Section
### Identification Module
**NCT ID:** NCT06414798

**Brief Title:** A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.

**Official Title:** A First-in-Human Single Ascending Dose and Mass Balance Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 in Healthy Adult Subjects

#### Organization Study ID Info
**ID:** M24-929
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
### Status Module
#### Completion Date
**Date:** 2024-11-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AbbVie

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants

### Conditions Module

**Conditions:**

- Healthy Volunteers

**Keywords:**

- Healthy Volunteers

- ABBV-1088

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive single dose of ABBV-1088 dose A on day 1

**Intervention Names:**

- Drug: Drug: ABBV-1088

**Label:** Group 1- ABBV-1088 Dose A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive single dose of placebo day 1

**Intervention Names:**

- Drug: Drug: Placebo for ABBV-1088

**Label:** Group 1- Placebo

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will receive single dose of ABBV-1088 dose B on day 1

**Intervention Names:**

- Drug: Drug: ABBV-1088

**Label:** Group 2- ABBV-1088 Dose B

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants will receive single dose of placebo day 1

**Intervention Names:**

- Drug: Drug: Placebo for ABBV-1088

**Label:** Group 2- Placebo

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Participants will receive single dose of ABBV-1088 dose C on day 1

**Intervention Names:**

- Drug: Drug: ABBV-1088

**Label:** Group 3- ABBV-1088 Dose C

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Participants will receive single dose of placebo day 1

**Intervention Names:**

- Drug: Drug: Placebo for ABBV-1088

**Label:** Group 3- Placebo

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** Participants will receive single dose of ABBV-1088 dose D on day 1

**Intervention Names:**

- Drug: Drug: ABBV-1088

**Label:** Group 4- ABBV-1088 Dose D

**Type:** EXPERIMENTAL

#### Arm Group 8

**Description:** Participants will receive single dose of placebo day 1

**Intervention Names:**

- Drug: Drug: Placebo for ABBV-1088

**Label:** Group 4- Placebo

**Type:** EXPERIMENTAL

#### Arm Group 9

**Description:** Participants will receive single dose of ABBV-1088 dose E on day 1

**Intervention Names:**

- Drug: Drug: ABBV-1088

**Label:** Group 5- ABBV-1088 Dose E

**Type:** EXPERIMENTAL

#### Arm Group 10

**Description:** Participants will receive single dose of placebo day 1

**Intervention Names:**

- Drug: Drug: Placebo for ABBV-1088

**Label:** Group 5- Placebo

**Type:** EXPERIMENTAL

#### Arm Group 11

**Description:** Participants will receive single dose of ABBV-1088 dose F on day 1

**Intervention Names:**

- Drug: Drug: ABBV-1088

**Label:** Group 6- ABBV-1088 Dose F

**Type:** EXPERIMENTAL

#### Arm Group 12

**Description:** Participants will receive single dose of placebo day 1

**Intervention Names:**

- Drug: Drug: Placebo for ABBV-1088

**Label:** Group 6- Placebo

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1- ABBV-1088 Dose A

- Group 2- ABBV-1088 Dose B

- Group 3- ABBV-1088 Dose C

- Group 4- ABBV-1088 Dose D

- Group 5- ABBV-1088 Dose E

- Group 6- ABBV-1088 Dose F

**Description:** • Oral Capsule

**Name:** Drug: ABBV-1088

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group 1- Placebo

- Group 2- Placebo

- Group 3- Placebo

- Group 4- Placebo

- Group 5- Placebo

- Group 6- Placebo

**Description:** • Oral Capsule

**Name:** Drug: Placebo for ABBV-1088

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Cmax of ABBV-1088

**Measure:** Maximum Plasma Concentration (Cmax) of ABBV-1088

**Time Frame:** Up to approximately 11 days

**Description:** Tmax of ABBV-1088

**Measure:** Time to Cmax (Tmax) of ABBV-1088

**Time Frame:** Up to approximately 11 days

**Description:** Terminal phase elimination rate constant (beta) of ABBV-1088

**Measure:** Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088

**Time Frame:** Up to approximately 11 days

**Description:** Terminal phase elimination half-life of ABBV-1088

**Measure:** Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088

**Time Frame:** Up to approximately 11 days

**Description:** AUCt of ABBV-1088

**Measure:** Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088

**Time Frame:** Up to approximately 11 days

**Description:** AUCinf of ABBV-1088

**Measure:** Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088

**Time Frame:** Up to approximately 11 days

**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study

**Measure:** Number of Participants With Adverse Events (AEs)

**Time Frame:** Up to Day 32

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

* History of cardiac disease, including congenital structural/conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmia.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, chronic GERD, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts within the last two years.
* History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** abbvieclinicaltrials@abbvie.com

**Name:** ABBVIE CALL CENTER

**Phone:** 844-663-3742

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Grayslake

**Country:** United States

**Facility:** Acpru /Id# 264249

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60030

#### Overall Officials

**Official 1:**

**Affiliation:** AbbVie

**Name:** ABBVIE INC.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Related Info

**URL:** https://www.abbvieclinicaltrials.com/study/?id=M24-929

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
