Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT06425003
- Run by
- Calico Life Sciences LLC
- People needed
- 7
- Starts
- 2024-05-21
- Expected to finish
- 2024-07-12
- Last updated by the study team
- 2024-07-19
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fortrea Clinical Research Unit Inc. — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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