A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABBV-903 Participants will receive ABBV-903 on Day 1. |
Drug: ABBV-903
Solution; Oral
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- M24-223