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ABBV-CLS-7262 for Healthy Volunteers
Phase 1
Waitlist Available
Research Sponsored by Calico Life Sciences LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 days from last dose.
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess how the body processes and eliminates a new medication called ABBV-CLS-7262 in healthy male volunteers after they take a single dose by mouth.
Who is the study for?
This trial is for healthy male volunteers who are interested in helping to study the balance and movement of a new drug within the body after taking it just once by mouth. Specific eligibility details aren't provided, but typically participants must meet certain health standards.
What is being tested?
[14C] ABBV-CLS-7262 is being tested to understand how it's processed in the body and its safety profile when given as a single oral dose. The focus is on tracking the drug's absorption, distribution, metabolism, and excretion.
What are the potential side effects?
Since this trial involves healthy individuals and detailed side effects are not listed, potential risks may include typical drug-related reactions such as nausea, headache, dizziness or allergic responses; however specific side effects will be monitored closely.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any significant ongoing health issues apart from my cancer.
Select...
I've been exposed to significant radiation for work or medical reasons, not including dental x-rays, in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 30 days from last dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 30 days from last dose.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)
Identification of metabolites excreted
Maximum observed concentration (Cmax)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: [14C] ABBV-CLS-7262Experimental Treatment1 Intervention
Participants will receive \[14C\] ABBV-CLS-7262 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[14C] ABBV-CLS-7262
2024
Completed Phase 1
~10
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Calico Life Sciences LLCLead Sponsor
9 Previous Clinical Trials
820 Total Patients Enrolled
AbbVieIndustry Sponsor
1,022 Previous Clinical Trials
520,172 Total Patients Enrolled
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