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Completed

NCT Number: NCT05895266

A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers

The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.

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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# 254970

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

  • BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
  • Negative test result for SARS-CoV-2 infection 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 ECG.

Exclusion criteria

  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  • History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.

Treatment and study plan

ABBV-903

Drug

Oral Tablet

midazolam

Drug

Oral Liquid

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 40 days

    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.

  2. Maximum Plasma Concentration (Cmax) of ABBV-903

    Time frame: Up to approximately 40 days

    Cmax of ABBV-903

  3. Maximum Plasma Concentration (Cmax) of Midazolam

    Time frame: Up to approximately 40 days

    Cmax of midazolam

  4. Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam

    Time frame: Up to approximately 40 days

    Cmax of 1-OH-midazolam

  5. Time to Cmax (Tmax) of ABBV-903

    Time frame: Up to approximately 40 days

    Tmax of ABBV-903

  6. Time to Cmax (Tmax) of Midazolam

    Time frame: Up to approximately 40 days

    Tmax of midazolam

  7. Time to Cmax (Tmax) of 1-OH-Midazolam

    Time frame: Up to approximately 40 days

    Tmax of 1-OH-midazolam

  8. Terminal Phase Elimination Half-Life (t1/2) of ABBV-903

    Time frame: Up to approximately 40 days

    Terminal phase elimination half-life of ABBV-903

  9. Terminal Phase Elimination Half-Life (t1/2) of Midazolam

    Time frame: Up to approximately 40 days

    Terminal phase elimination half-life of midazolam

  10. Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam

    Time frame: Up to approximately 40 days

    Terminal phase elimination half-life of 1-OH-midazolam

  11. Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903

    Time frame: Up to approximately 40 days

    AUCt of ABBV-903

  12. Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam

    Time frame: Up to approximately 40 days

    AUCt of midazolam

  13. Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam

    Time frame: Up to approximately 40 days

    AUCt of 1-OH-midazolam

  14. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903

    Time frame: Up to approximately 40 days

    AUCinf of ABBV-903

  15. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam

    Time frame: Up to approximately 40 days

    AUCinf of midazolam

  16. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam

    Time frame: Up to approximately 40 days

    AUCinf of 1-OH-midazolam

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Nov 9, 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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