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

NCT ID: NCT06425003

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2024-07-12

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[14C] ABBV-CLS-7262

Participants will receive \[14C\] ABBV-CLS-7262 on Day 1.

Group Type: EXPERIMENTAL

[14C] ABBV-CLS-7262

Intervention Type: DRUG

Oral Solution

Interventions

[14C] ABBV-CLS-7262

Oral Solution

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Calico Life Sciences LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

M24-326

Identifier Type: -

Identifier Source: org_study_id