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

NCT05895266 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-225
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-903; Midazolam

Outcome Measures

Primary Outcomes (16)

• 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.

  Up to approximately 40 days

• Maximum Plasma Concentration (Cmax) of ABBV-903

  Cmax of ABBV-903

  Up to approximately 40 days

• Maximum Plasma Concentration (Cmax) of Midazolam

  Cmax of midazolam

  Up to approximately 40 days

• Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam

  Cmax of 1-OH-midazolam

  Up to approximately 40 days

• Time to Cmax (Tmax) of ABBV-903

  Tmax of ABBV-903

  Up to approximately 40 days

• Time to Cmax (Tmax) of Midazolam

  Tmax of midazolam

  Up to approximately 40 days

• Time to Cmax (Tmax) of 1-OH-Midazolam

  Tmax of 1-OH-midazolam

  Up to approximately 40 days

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

  Terminal phase elimination half-life of ABBV-903

  Up to approximately 40 days

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

  Terminal phase elimination half-life of midazolam

  Up to approximately 40 days

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

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

  Up to approximately 40 days

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

  AUCt of ABBV-903

  Up to approximately 40 days

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

  AUCt of midazolam

  Up to approximately 40 days

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

  AUCt of 1-OH-midazolam

  Up to approximately 40 days

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

  AUCinf of ABBV-903

  Up to approximately 40 days

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

  AUCinf of midazolam

  Up to approximately 40 days

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

  AUCinf of 1-OH-midazolam

  Up to approximately 40 days

Study Arms (4)

Part 1: Period 1

EXPERIMENTAL

In Period 1 on Day 1, participants will receive liquid midazolam.

Drug: Midazolam

Part 1: Period 2

EXPERIMENTAL

In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.

Drug: ABBV-903; Drug: Midazolam

Part 2: Period 1

EXPERIMENTAL

In Period 1 on Day 1, participants will receive liquid midazolam.

Drug: Midazolam

Part 2: Period 2

EXPERIMENTAL

In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.

Drug: ABBV-903; Drug: Midazolam

Interventions

ABBV-903 DRUG

Oral Tablet

Part 1: Period 2; Part 2: Period 2

Midazolam DRUG

Oral Liquid

Part 1: Period 1; Part 1: Period 2; Part 2: Period 1; Part 2: Period 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 254970

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: June 23, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)