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

NCT06425003 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-326
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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.

• Maximum observed concentration (Cmax)

  Cmax will be assessed.

  Up to approximately Day 15 from last dose

• Time to Cmax (peak time, Tmax)

  Tmax will be assessed.

  Up to approximately 15 days from last dose

• 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

• 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

• Percent radioactivity excreted

  Percentage total radioactivity

  Up to approximately 15 days from last dose

• Identification of metabolites excreted

  Identification of the major metabolites

  Up to approximately 15 days from last dose

Study Arms (1)

[14C] ABBV-CLS-7262

EXPERIMENTAL

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

Drug: [14C] ABBV-CLS-7262

Interventions

[14C] ABBV-CLS-7262 DRUG

Oral Solution

[14C] ABBV-CLS-7262

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Calico Life Sciences LLC: lead
• AbbVie: collaborator

Study Sites (1)

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 22, 2024
• Study Start: May 21, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)