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A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis (ABBV-576 DDI)

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Galicaftor
ABBV-576
Navocaftor
Midazolam
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers focused on measuring Galicaftor, Navocaftor, ABBV-576, Cystic Fibrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths decimal.
  • 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 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.
  • History of any clinically significant sensitivity or allergy to any medication or food.
  • History of any clinically significant condition listed in the protocol.

Sites / Locations

  • Anaheim Clinical Trials LLC /ID# 248824
  • Clinical Pharmacology of Miami /ID# 248823
  • PPD Clinical Research Unit -Las Vegas /ID# 248853
  • PPD Clinical Research Unit - Austin /ID# 248854

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ABBV-576 with Galicaftor + Navocaftor

Navocaftor + Galicaftor with ABBV 576

Optional: Navocaftor with ABBV 576

Optional: Galicaftor with ABBV 576

Optional: Midazolam with ABBV-576 + Navocaftor

Arm Description

Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.

Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.

Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days.

Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.

Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax)
Cmax will be assessed.
Time to maximum observed plasma concentration (Tmax)
Tmax will be assessed.
Apparent terminal phase elimination rate constant (BETA or β)
Apparent terminal phase elimination rate constant (BETA or β) will be assessed.
Mean terminal phase elimination half-life (t1/2)
T1/2 will be assessed.
Area under the plasma curve (AUC)
AUC will be assessed.
Number of Participants With Adverse Events (AEs)
An adverse event (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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2022
Last Updated
February 16, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05530278
Brief Title
A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis
Acronym
ABBV-576 DDI
Official Title
Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Galicaftor, Navocaftor, ABBV-576, Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABBV-576 with Galicaftor + Navocaftor
Arm Type
Experimental
Arm Description
Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.
Arm Title
Navocaftor + Galicaftor with ABBV 576
Arm Type
Experimental
Arm Description
Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Arm Title
Optional: Navocaftor with ABBV 576
Arm Type
Experimental
Arm Description
Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days.
Arm Title
Optional: Galicaftor with ABBV 576
Arm Type
Experimental
Arm Description
Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.
Arm Title
Optional: Midazolam with ABBV-576 + Navocaftor
Arm Type
Experimental
Arm Description
Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.
Intervention Type
Drug
Intervention Name(s)
Galicaftor
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
ABBV-576
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Navocaftor
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Description
Cmax will be assessed.
Time Frame
Up to Day 52
Title
Time to maximum observed plasma concentration (Tmax)
Description
Tmax will be assessed.
Time Frame
Up to Day 52
Title
Apparent terminal phase elimination rate constant (BETA or β)
Description
Apparent terminal phase elimination rate constant (BETA or β) will be assessed.
Time Frame
Up to Day 52
Title
Mean terminal phase elimination half-life (t1/2)
Description
T1/2 will be assessed.
Time Frame
Up to Day 52
Title
Area under the plasma curve (AUC)
Description
AUC will be assessed.
Time Frame
Up to Day 52
Title
Number of Participants With Adverse Events (AEs)
Description
An adverse event (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.
Time Frame
Up to Day 82

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths decimal. 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 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. History of any clinically significant sensitivity or allergy to any medication or food. History of any clinically significant condition listed in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials LLC /ID# 248824
City
Anaheim
State/Province
California
ZIP/Postal Code
92801-2658
Country
United States
Facility Name
Clinical Pharmacology of Miami /ID# 248823
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
PPD Clinical Research Unit -Las Vegas /ID# 248853
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113-2235
Country
United States
Facility Name
PPD Clinical Research Unit - Austin /ID# 248854
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis

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