NCT05691699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

January 9, 2023

Last Update Submit

October 27, 2023

Conditions

Healthy Volunteer

Keywords

ABBV-903

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (6)

Part 1, ABBV-903

EXPERIMENTAL

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

Drug: ABBV-903

Part 1, Placebo

EXPERIMENTAL

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

Drug: Placebo for ABBV-903

Part 2, ABBV-903

EXPERIMENTAL

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

Drug: ABBV-903

Part 2, Placebo

EXPERIMENTAL

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

Drug: Placebo for ABBV-903

Part 3, Sequence 1

EXPERIMENTAL

Participants in Part 3 will follow Sequence 1.

Drug: ABBV-903Drug: Itraconazole

Part 3, Sequence 2

EXPERIMENTAL

Participants in Part 3 will follow Sequence 2.

Drug: ABBV-903Drug: Itraconazole

Interventions

ABBV-903DRUG

Capsule; oral

Part 1, ABBV-903Part 2, ABBV-903Part 3, Sequence 1Part 3, Sequence 2
Placebo for ABBV-903DRUG

Capsule; oral

Part 1, PlaceboPart 2, Placebo
ItraconazoleDRUG

Capsule; oral

Part 3, Sequence 1Part 3, Sequence 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acpru /Id# 251279

Grayslake, Illinois, 60030, United States

Location

Related Links

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 20, 2023

Study Start

January 3, 2023

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)