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A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults

A Phase 1 First in Human, Single and Multiple Ascending Dose and Food Effect and Drug-Drug Interaction in Healthy Subjects to Evaluate the Safety, Tolerability and Assessment of Pharmacokinetics of ABBV-903

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05691699
Enrollment
104
Registered
2023-01-20
Start date
2023-01-03
Completion date
2023-10-23
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

ABBV-903

Brief summary

The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.

Interventions

DRUGABBV-903

Capsule; oral

DRUGPlacebo for ABBV-903

Capsule; oral

DRUGItraconazole

Capsule; oral

Sponsors

AbbVie
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Body Mass Index (BMI) is =\> 18.0 to \<= 32 kg/m2 after rounded to the nearest tenth, 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 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), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Design outcomes

Primary

MeasureTime frameDescription
Maximum Observed Plasma Concentration (Cmax)Baseline to Day 36Cmax will be assessed.
Time to Cmax (Tmax)Baseline to Day 36Tmax will be assessed.
Apparent Terminal Phase Elimination Constant (β)Baseline to Day 36Apparent terminal phase elimination constant (β) will be assessed.
Terminal Phase Elimination Half-life (t1/2)Baseline to Day 36Terminal phase elimination half-life (t1/2) will be assessed.
Area Under the Plasma Concentration-time Curve (AUC)Baseline to Day 36AUC will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)Baseline to Day 36AUCt will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)Baseline to Day 36AUCinf will be assessed.
Number of Participants with Adverse Events (AEs)Baseline to Day 66An 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026