Healthy VolunteerPhase 1NCT05995366
A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration
A Phase 1 study testing ABBV-903 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-903
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2023to 13 Oct 2023
- Phase
- Phase 1
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc. /ID# 253962
Madison, Wisconsin, 53704
About this study
Official title: Mass Balance Study of [14C] ABBV-903 in Healthy Male Subjects Following Single Oral Dose Administration
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
- Being tested
- ABBV-903
- Keywords
- Healthy Volunteer, ABBV-903
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-903Drug
Solution; Oral
| Study group | Role | What they receive |
|---|---|---|
| ABBV-903 | Experimental | Participants will receive ABBV-903 on Day 1. Receives: Drug: ABBV-903 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of ABBV-903
Cmax of ABBV-903 will be assessed.
Measured: Up to Day 16
Time to Cmax (peak time, Tmax) of ABBV-903
Tmax of ABBV-903 will be assessed.
Measured: Up to Day 16
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
Terminal phase elimination half-life (t1/2) will be assessed.
Measured: 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.
Measured: Up to Day 16
AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903
AUC0-inf of ABBV-903 will be assessed.
Measured: 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.
Measured: Baseline to Day 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start18 Aug 2023
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995366
- Sponsor's protocol ID
- M24-223
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No