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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414798
• Other study ID #: M24-929
• Status: Recruiting
• Phase: Phase 1
• Start date: May 13, 2024
• Est. completion date: November 28, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 28, 2024
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Drug: ABBV-1088
• Oral Capsule
• Drug: Placebo for ABBV-1088
• Oral Capsule

Locations

Country	Name	City	State
United States	Acpru /Id# 264249	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of ABBV-1088	Cmax of ABBV-1088	Up to approximately 11 days
Primary	Time to Cmax (Tmax) of ABBV-1088	Tmax of ABBV-1088	Up to approximately 11 days
Primary	Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088	Terminal phase elimination rate constant (beta) of ABBV-1088	Up to approximately 11 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088	Terminal phase elimination half-life of ABBV-1088	Up to approximately 11 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088	AUCt of ABBV-1088	Up to approximately 11 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088	AUCinf of ABBV-1088	Up to approximately 11 days
Primary	Number of Participants With Adverse Events (AEs)	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	Up to Day 32

External Links

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