A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration

Healthy Volunteer Clinical Trial

Official title:

Mass Balance Study of [14C] ABBV-903 in Healthy Male Subjects Following Single Oral Dose Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05995366
• Other study ID #: M24-223
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2023
• Est. completion date: October 13, 2023

Study information

• Verified date: October 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in healthy male volunteers following a single oral dose administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness

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

• Consider fathering a child or donating sperm during the study and for 94 days after study drug administration.

• Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ABBV-903
Solution; Oral

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit Inc. /ID# 253962	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax) of ABBV-903	Cmax of ABBV-903 will be assessed.	Up to Day 16
Primary	Time to Cmax (peak time, Tmax) of ABBV-903	Tmax of ABBV-903 will be assessed.	Up to Day 16
Primary	Terminal Phase Elimination Half-life (t1/2) of ABBV-903	Terminal phase elimination half-life (t1/2) will be assessed.	Up to Day 16
Primary	Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903	AUC0-t of ABBV-903 will be assessed.	Up to Day 16
Primary	AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903	AUC0-inf of ABBV-903 will be assessed.	Up to Day 16
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.	Baseline to Day 46

External Links

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