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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Drug: Placebo for ABBV-1088; Drug: Drug: ABBV-1088

Study type: Interventional

Funder types: Industry

Identifiers

NCT06414798

M24-929

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 12 patient groups

Group 1- ABBV-1088 Dose A

Experimental group

Description:

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

Treatment:

Drug: Drug: ABBV-1088

Group 1- Placebo

Experimental group

Description:

Participants will receive single dose of placebo day 1

Treatment:

Drug: Drug: Placebo for ABBV-1088

Group 2- ABBV-1088 Dose B

Experimental group

Description:

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

Treatment:

Drug: Drug: ABBV-1088

Group 2- Placebo

Experimental group

Description:

Participants will receive single dose of placebo day 1

Treatment:

Drug: Drug: Placebo for ABBV-1088

Group 3- ABBV-1088 Dose C

Experimental group

Description:

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

Treatment:

Drug: Drug: ABBV-1088

Group 3- Placebo

Experimental group

Description:

Participants will receive single dose of placebo day 1

Treatment:

Drug: Drug: Placebo for ABBV-1088

Group 4- ABBV-1088 Dose D

Experimental group

Description:

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

Treatment:

Drug: Drug: ABBV-1088

Group 4- Placebo

Experimental group

Description:

Participants will receive single dose of placebo day 1

Treatment:

Drug: Drug: Placebo for ABBV-1088

Group 5- ABBV-1088 Dose E

Experimental group

Description:

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

Treatment:

Drug: Drug: ABBV-1088

Group 5- Placebo

Experimental group

Description:

Participants will receive single dose of placebo day 1

Treatment:

Drug: Drug: Placebo for ABBV-1088

Group 6- ABBV-1088 Dose F

Experimental group

Description:

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

Treatment:

Drug: Drug: ABBV-1088

Group 6- Placebo

Experimental group

Description:

Participants will receive single dose of placebo day 1

Treatment:

Drug: Drug: Placebo for ABBV-1088