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

NCT ID: NCT06414798

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-13

Study Completion Date

2025-02-08

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1- ABBV-1088 Dose A

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

Group Type EXPERIMENTAL

Drug: ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 1- Placebo

Participants will receive single dose of placebo day 1

Group Type EXPERIMENTAL

Drug: Placebo for ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 2- ABBV-1088 Dose B

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

Group Type EXPERIMENTAL

Drug: ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 2- Placebo

Participants will receive single dose of placebo day 1

Group Type EXPERIMENTAL

Drug: Placebo for ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 3- ABBV-1088 Dose C

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

Group Type EXPERIMENTAL

Drug: ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 3- Placebo

Participants will receive single dose of placebo day 1

Group Type EXPERIMENTAL

Drug: Placebo for ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 4- ABBV-1088 Dose D

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

Group Type EXPERIMENTAL

Drug: ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 4- Placebo

Participants will receive single dose of placebo day 1

Group Type EXPERIMENTAL

Drug: Placebo for ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 5- ABBV-1088 Dose E

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

Group Type EXPERIMENTAL

Drug: ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 5- Placebo

Participants will receive single dose of placebo day 1

Group Type EXPERIMENTAL

Drug: Placebo for ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 6- ABBV-1088 Dose F

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

Group Type EXPERIMENTAL

Drug: ABBV-1088

Intervention Type DRUG

• Oral Capsule

Group 6- Placebo

Participants will receive single dose of placebo day 1

Group Type EXPERIMENTAL

Drug: Placebo for ABBV-1088

Intervention Type DRUG

• Oral Capsule

Interventions

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Drug: ABBV-1088

• Oral Capsule

Intervention Type DRUG

Drug: Placebo for ABBV-1088

• Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Acpru /Id# 264249

Grayslake, Illinois, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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M24-929

Identifier Type: -

Identifier Source: org_study_id

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