Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration

Healthy Volunteer Clinical Trial

Official title:

Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425003
• Other study ID #: M24-326
• Status: Recruiting
• Phase: Phase 1
• Start date: May 21, 2024
• Est. completion date: July 11, 2024

Study information

• Verified date: May 2024
• Source: Calico Life Sciences LLC
• Contact: AbbVie Call Center
• Phone: +1 (844) 663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: July 11, 2024
• Est. primary completion date: July 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• [14C] ABBV-CLS-7262
Oral Solution

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Calico Life Sciences LLC	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)	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.	Up to approximately 30 days from last dose.
Primary	Maximum observed concentration (Cmax)	Cmax will be assessed.	Up to approximately Day 15 from last dose
Primary	Time to Cmax (peak time, Tmax)	Tmax will be assessed.	Up to approximately 15 days from last dose
Primary	Terminal phase elimination half-life (t1/2)	Terminal phase elimination half-life (t1/2) will be assessed.	Up to approximately 15 days from last dose
Primary	Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)	AUCt will be assessed.	Up to approximately 15 days from last dose
Primary	Percent radioactivity excreted	Percentage total radioactivity	Up to approximately 15 days from last dose
Primary	Identification of metabolites excreted	Identification of the major metabolites	Up to approximately 15 days from last dose