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

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05895266

Collaborator

(none)

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: ABBV-903 Drug: Midazolam	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Aug 21, 2023

Anticipated Study Completion Date :

Aug 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Period 1 In Period 1 on Day 1, participants will receive liquid midazolam.	Drug: Midazolam Oral Liquid
Experimental: Part 1: Period 2 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 Oral Tablet Drug: Midazolam Oral Liquid
Experimental: Part 2: Period 1 In Period 1 on Day 1, participants will receive liquid midazolam.	Drug: Midazolam Oral Liquid
Experimental: Part 2: Period 2 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 Oral Tablet Drug: Midazolam Oral Liquid

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events (AEs) [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.
Maximum Plasma Concentration (Cmax) of ABBV-903 [Up to approximately 40 days]
Cmax of ABBV-903
Maximum Plasma Concentration (Cmax) of Midazolam [Up to approximately 40 days]
Cmax of midazolam
Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam [Up to approximately 40 days]
Cmax of 1-OH-midazolam
Time to Cmax (Tmax) of ABBV-903 [Up to approximately 40 days]
Tmax of ABBV-903
Time to Cmax (Tmax) of Midazolam [Up to approximately 40 days]
Tmax of midazolam
Time to Cmax (Tmax) of 1-OH-Midazolam [Up to approximately 40 days]
Tmax of 1-OH-midazolam
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903 [Up to approximately 40 days]
Terminal phase elimination half-life of ABBV-903
Terminal Phase Elimination Half-Life (t1/2) of Midazolam [Up to approximately 40 days]
Terminal phase elimination half-life of midazolam
Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam [Up to approximately 40 days]
Terminal phase elimination half-life of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903 [Up to approximately 40 days]
AUCt of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam [Up to approximately 40 days]
AUCt of midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam [Up to approximately 40 days]
AUCt of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903 [Up to approximately 40 days]
AUCinf of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam [Up to approximately 40 days]
AUCinf of midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam [Up to approximately 40 days]
AUCinf of 1-OH-midazolam

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acpru /Id# 254970	Grayslake	Illinois	United States	60030

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT05895266

Other Study ID Numbers:

M24-225

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

Healthy Volunteer

ABBV-903

Midazolam

Additional relevant MeSH terms:

Midazolam

Study Results

No Results Posted as of Jun 8, 2023