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

Healthy Volunteers Clinical Trial

Official title:

Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06078202
• Other study ID #: M24-231
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 5, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: October 2023
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal, at screening 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 electrocardiogram (ECG).

Exclusion Criteria:

• History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABBV-903
Tablet; oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of ABBV-903	Cmax of ABBV-903 will be assessed.	From 0 - 96 hours
Primary	Time to Cmax (Tmax) of ABBV-903	Tmax of ABBV-903 will be assessed.	From 0 - 96 hours
Primary	Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903	BETA of ABBV-903 will be assessed.	From 0 - 96 hours
Primary	Terminal Phase Elimination Half-life (t1/2) of ABBV-903	Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.	From 0 - 96 hours
Primary	Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903	AUC0-24 of ABBV-903 will be assessed.	From 0 - 96 hours
Primary	AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903	AUCt of ABBV-903 will be assessed.	From 0 - 96 hours
Primary	AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903	AUCinf of ABBV-903 will be assessed.	From 0 - 96 hours
Primary	Number of Participants with Adverse Events	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.	Up to 42 days

External Links

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