Healthy Volunteer
Conditions
Brief summary
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.
Interventions
DRUG[14C] ABBV-CLS-7262
Oral Solution
Sponsors
AbbVie
Calico Life Sciences LLC
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
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG. * Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.
Exclusion criteria
* Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations. * 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, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness. * 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 |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to approximately 30 days from last dose. | 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. |
| Maximum observed concentration (Cmax) | Up to approximately Day 15 from last dose | Cmax will be assessed. |
| Time to Cmax (peak time, Tmax) | Up to approximately 15 days from last dose | Tmax will be assessed. |
| Terminal phase elimination half-life (t1/2) | Up to approximately 15 days from last dose | 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 (AUCt) | Up to approximately 15 days from last dose | AUCt will be assessed. |
| Percent radioactivity excreted | Up to approximately 15 days from last dose | Percentage total radioactivity |
| Identification of metabolites excreted | Up to approximately 15 days from last dose | Identification of the major metabolites |
Countries
United States
Outcome results
None listed