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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2023-10-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ABBV-903

Participants will receive ABBV-903 on Day 1.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Solution; Oral

Interventions

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ABBV-903

Solution; Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes