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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895266
• Other study ID #: M24-225
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ABBV-903
Oral Tablet
• Midazolam
Oral Liquid

Locations

Country	Name	City	State
United States	Acpru /Id# 254970	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Plasma Concentration (Cmax) of ABBV-903	Cmax of ABBV-903	Up to approximately 40 days
Primary	Maximum Plasma Concentration (Cmax) of Midazolam	Cmax of midazolam	Up to approximately 40 days
Primary	Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam	Cmax of 1-OH-midazolam	Up to approximately 40 days
Primary	Time to Cmax (Tmax) of ABBV-903	Tmax of ABBV-903	Up to approximately 40 days
Primary	Time to Cmax (Tmax) of Midazolam	Tmax of midazolam	Up to approximately 40 days
Primary	Time to Cmax (Tmax) of 1-OH-Midazolam	Tmax of 1-OH-midazolam	Up to approximately 40 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-903	Terminal phase elimination half-life of ABBV-903	Up to approximately 40 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of Midazolam	Terminal phase elimination half-life of midazolam	Up to approximately 40 days
Primary	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
Primary	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
Primary	Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam	AUCt of midazolam	Up to approximately 40 days
Primary	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
Primary	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903	AUCinf of ABBV-903	Up to approximately 40 days
Primary	Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam	AUCinf of midazolam	Up to approximately 40 days
Primary	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

External Links

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