Clinical trial

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

Name

M24-112

Description

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.

Trial arms

Trial start

2023-01-03

Estimated PCD

2023-10-23

Trial end

2023-10-23

Status

Completed

Phase

Early phase I

Treatment

ABBV-903

Capsule; oral

Arms:

Part 1, ABBV-903, Part 2, ABBV-903, Part 3, Sequence 1, Part 3, Sequence 2

Placebo for ABBV-903

Capsule; oral

Arms:

Part 1, Placebo, Part 2, Placebo

Itraconazole

Capsule; oral

Arms:

Part 3, Sequence 1, Part 3, Sequence 2

Size

104

Primary endpoint

Maximum Observed Plasma Concentration (Cmax)

Baseline to Day 36

Time to Cmax (Tmax)

Baseline to Day 36

Apparent Terminal Phase Elimination Constant (β)

Baseline to Day 36

Terminal Phase Elimination Half-life (t1/2)

Baseline to Day 36

Area Under the Plasma Concentration-time Curve (AUC)

Baseline to Day 36

Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)

Baseline to Day 36

Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)

Baseline to Day 36

Number of Participants with Adverse Events (AEs)

Baseline to Day 66

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

Updated at

2023-10-30

1 organization

2 products

1 indication

Organization

Product

Indication

Product