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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: ABBV-903


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-903<br>Participants will receive ABBV-903 on Day 1. | Drug: ABBV-903<br>* Solution; Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) of ABBV-903 | Cmax of ABBV-903 will be assessed. | Up to Day 16 | 
| Time to Cmax (peak time, Tmax) of ABBV-903 | Tmax of ABBV-903 will be assessed. | Up to Day 16 | 
| Terminal Phase Elimination Half-life (t1/2) of ABBV-903 | Terminal phase elimination half-life (t1/2) will be assessed. | Up to Day 16 | 
| 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 | 
| AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903 | AUC0-inf of ABBV-903 will be assessed. | Up to Day 16 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer, ABBV-903