A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration

NCT05995366 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-223
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the mass balance and safety of \[14C\] ABBV-903 in healthy male volunteers following a single oral dose administration.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-903

Outcome Measures

Primary Outcomes (6)

• Maximum observed concentration (Cmax) of ABBV-903

  Cmax of ABBV-903 will be assessed.

  Up to Day 16

• Time to Cmax (peak time, Tmax) of ABBV-903

  Tmax of ABBV-903 will be assessed.

  Up to Day 16

• Terminal Phase Elimination Half-life (t1/2) of ABBV-903

  Terminal phase elimination half-life (t1/2) will be assessed.

  Up to Day 16

• Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903

  AUC0-t of ABBV-903 will be assessed.

  Up to Day 16

• AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903

  AUC0-inf of ABBV-903 will be assessed.

  Up to Day 16

• 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.

  Baseline to Day 46

Study Arms (1)

ABBV-903

EXPERIMENTAL

Participants will receive ABBV-903 on Day 1.

Drug: ABBV-903

Interventions

ABBV-903 DRUG

Solution; Oral

ABBV-903

Eligibility Criteria

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

You may qualify if:

• Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at Screening and upon initial confinement.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

You may not qualify if:

• History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
• History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to study drug administration.
• Consider fathering a child or donating sperm during the study and for 94 days after study drug administration.
• 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

• AbbVie: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc. /ID# 253962

Madison, Wisconsin, 53704, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

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: August 10, 2023
• First Posted: August 16, 2023
• Study Start: August 18, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)