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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-10-23

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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1, ABBV-903

Participants will receive a single ascending dose of ABBV-903 in Part 1.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Capsule; oral

Part 1, Placebo

Participants will receive a single ascending dose of placebo in Part 1.

Group Type EXPERIMENTAL

Placebo for ABBV-903

Intervention Type DRUG

Capsule; oral

Part 2, ABBV-903

Participants will receive multiple ascending doses of ABBV-903 in Part 2.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Capsule; oral

Part 2, Placebo

Participants will receive multiple ascending doses of placebo in Part 2.

Group Type EXPERIMENTAL

Placebo for ABBV-903

Intervention Type DRUG

Capsule; oral

Part 3, Sequence 1

Participants in Part 3 will follow Sequence 1.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Capsule; oral

Itraconazole

Intervention Type DRUG

Capsule; oral

Part 3, Sequence 2

Participants in Part 3 will follow Sequence 2.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Capsule; oral

Itraconazole

Intervention Type DRUG

Capsule; oral

Interventions

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ABBV-903

Capsule; oral

Intervention Type DRUG

Placebo for ABBV-903

Capsule; oral

Intervention Type DRUG

Itraconazole

Capsule; oral

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes