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NCT05836506 Clinical Trial

A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants

Healthy Volunteer Clinical Trial

Official title:
Assessment of the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05836506
Other study ID # M24-226
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 18, 2023
Est. completion date June 20, 2023

Study information
Verified date July 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to assess the relative bioavailability and pharmacokinetics of ABBV-903 in healthy adult participants.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 20, 2023
Est. primary completion date June 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - BMI is = 18.0 to = 32 kg/m2 after rounding to the tenth. - Negative test result for SARS-CoV-2 infection at screening visit and upon initial confinement. - 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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. - History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ABBV-903 Tablet Form 1
Oral Tablets
• ABBV-903 Tablet Form 2
Oral Tablets

Locations
Country Name City State
United States Acpru /Id# 254926 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 Number of Participants with Adverse Events (AEs) An 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 Up to Approximately 44 days
Primary Maximum Plasma Concentration (Cmax) of ABBV-903 Cmax of ABBV-903 Up to approximately 14 days
Primary Time to Cmax (Tmax) of ABBV-903 Tmax of ABBV-903 Up to approximately 14 days
Primary Terminal Phase Elimination Half-Life (t1/2) of ABBV-903 Terminal phase elimination half-life of ABBV-903 Up to approximately 14 days
Primary Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903 AUCt of ABBV-903 Up to approximately 14 days
Primary Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903 AUCinf of ABBV-903 Up to approximately 14 days
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