Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
- Registration Number
- NCT06425003
- Lead Sponsor
- Calico Life Sciences LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C] ABBV-CLS-7262 [14C] ABBV-CLS-7262 Participants will receive \[14C\] ABBV-CLS-7262 on Day 1.
- Primary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Up to approximately Day 15 from last dose Cmax will be assessed.
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.
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.
Time to Cmax (peak time, Tmax) Up to approximately 15 days from last dose Tmax 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
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc.
🇺🇸Madison, Wisconsin, United States