Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Calico Life Sciences LLC
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Maximum observed concentration (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
[14C] ABBV-CLS-7262
Participants will receive [14C] ABBV-CLS-7262 on Day 1.
Intervention: [14C] ABBV-CLS-7262 (Drug)
Outcomes
Primary Outcomes
Maximum observed concentration (Cmax)
Time Frame: Up to approximately Day 15 from last dose
Cmax will be assessed.
Number of Participants with Adverse Events (AEs)
Time Frame: 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.
Terminal phase elimination half-life (t1/2)
Time Frame: Up to approximately 15 days from last dose
Terminal phase elimination half-life (t1/2) will be assessed.
Time to Cmax (peak time, Tmax)
Time Frame: Up to approximately 15 days from last dose
Tmax will be assessed.
Percent radioactivity excreted
Time Frame: Up to approximately 15 days from last dose
Percentage total radioactivity
Identification of metabolites excreted
Time Frame: Up to approximately 15 days from last dose
Identification of the major metabolites
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)
Time Frame: Up to approximately 15 days from last dose
AUCt will be assessed.
Secondary Outcomes
No secondary outcomes reported