Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-903
Brief 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.
Interventions
DRUGABBV-903
Solution; Oral
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed concentration (Cmax) of ABBV-903 | Up to Day 16 | Cmax of ABBV-903 will be assessed. |
| Time to Cmax (peak time, Tmax) of ABBV-903 | Up to Day 16 | Tmax of ABBV-903 will be assessed. |
| Terminal Phase Elimination Half-life (t1/2) of ABBV-903 | Up to Day 16 | Terminal phase elimination half-life (t1/2) will be assessed. |
| Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903 | Up to Day 16 | AUC0-t of ABBV-903 will be assessed. |
| AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903 | Up to Day 16 | AUC0-inf of ABBV-903 will be assessed. |
| Number of Participants with Adverse Events (AEs) | Baseline to Day 46 | 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. |
Countries
United States
Outcome results
None listed