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OpenTrials
Completed

NCT Number: NCT05691699

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

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 251279

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-903

Drug

Capsule; oral

Placebo for ABBV-903

Drug

Capsule; oral

Itraconazole

Drug

Capsule; oral

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Baseline to Day 36

    Cmax will be assessed.

  2. Time to Cmax (Tmax)

    Time frame: Baseline to Day 36

    Tmax will be assessed.

  3. Apparent Terminal Phase Elimination Constant (β)

    Time frame: Baseline to Day 36

    Apparent terminal phase elimination constant (β) will be assessed.

  4. Terminal Phase Elimination Half-life (t1/2)

    Time frame: Baseline to Day 36

    Terminal phase elimination half-life (t1/2) will be assessed.

  5. Area Under the Plasma Concentration-time Curve (AUC)

    Time frame: Baseline to Day 36

    AUC will be assessed.

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

    Time frame: Baseline to Day 36

    AUCt will be assessed.

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

    Time frame: Baseline to Day 36

    AUCinf will be assessed.

  8. Number of Participants with Adverse Events (AEs)

    Time frame: Baseline to Day 66

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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