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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: ABBV-903
* Drug: Placebo for ABBV-903
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, ABBV-903<br>Participants will receive a single ascending dose of ABBV-903 in Part 1. | Drug: ABBV-903<br>* Capsule; oral<br>|
| Experimental: Part 1, Placebo<br>Participants will receive a single ascending dose of placebo in Part 1. | Drug: Placebo for ABBV-903<br>* Capsule; oral<br>|
| Experimental: Part 2, ABBV-903<br>Participants will receive multiple ascending doses of ABBV-903 in Part 2. | Drug: ABBV-903<br>* Capsule; oral<br>|
| Experimental: Part 2, Placebo<br>Participants will receive multiple ascending doses of placebo in Part 2. | Drug: Placebo for ABBV-903<br>* Capsule; oral<br>|
| Experimental: Part 3, Sequence 1<br>Participants in Part 3 will follow Sequence 1. | Drug: ABBV-903<br>* Capsule; oral<br>Drug: Itraconazole<br>* Capsule; oral<br>|
| Experimental: Part 3, Sequence 2<br>Participants in Part 3 will follow Sequence 2. | Drug: ABBV-903<br>* Capsule; oral<br>Drug: Itraconazole<br>* Capsule; oral<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-903