A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 55 years
• Men only
• Healthy volunteers accepted
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Mass Balance Study of [14C] ABBV-552 in Healthy Male Volunteers Following Single Oral Dose Administration

Conditions

Healthy Volunteer

Being tested

ABBV-552

Keywords

Healthy Volunteer, ABBV-552

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ABBV-552Drug

  Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Up to approximately 30 days

2. Maximum observed concentration (Cmax) of ABBV-552

   Cmax of ABBV-552 will be assessed.

   Measured: Up to approximately Day 15

3. Time to Cmax (peak time, Tmax) of ABBV-552

   Tmax of ABBV-552 will be assessed.

   Measured: Up to approximately 15 days

4. Terminal phase elimination rate constant (λz) of ABBV-552

   Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed.

   Measured: Up to approximately 15 days

5. Terminal phase elimination half-life (t1/2) of ABBV-552

   Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed.

   Measured: Up to approximately 15 days

6. Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552

   AUCt of ABBV-552 will be assessed.

   Measured: Up to approximately 15 days

7. Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552

   AUCinf of ABBV-552 will be assessed.

   Measured: Up to approximately 15 days

8. Amount of ABBV-552 excreted in the urine over the sampling period (Aeu)

   Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed.

   Measured: Up to approximately 15 days

9. Percent of ABBV-552 excreted in the urine

   Percent excreted = 100 × (Aeu/dose).

   Measured: Up to approximately 15 days

10. Renal clearance ABBV-552 (CLr)

    Renal clearance of ABBV-552 will be assessed.

    Measured: Up to approximately 15 days

11. Amount of ABBV-552 excreted in the feces over the sampling period (Aef)

    Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed.

    Measured: Up to approximately 15 days

12. Percent radioactivity excreted in the feces

    Percent excreted = 100 × (Aef/dose).

    Measured: Up to approximately 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 Feb 2024
2. Study start21 Feb 2024
3. Primary completion19 Apr 2024
4. Study completion19 Apr 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Healthy VolunteerStudies of the same condition, open and under way.
• More trials run by AbbVieThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.