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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ABBV-903; Drug: Placebo for ABBV-903; Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 251279

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ABBV-903
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: M24-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes