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

AbbVie24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

GalicaftorDRUG

Oral

ABBV-576DRUG

Oral

NavocaftorDRUG

Oral

MidazolamDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Anaheim Clinical Trials LLC /ID# 248824

Anaheim, California, United States

Clinical Pharmacology of Miami /ID# 248823

Miami, Florida, United States

PPD Clinical Research Unit -Las Vegas /ID# 248853

Las Vegas, Nevada, United States

PPD Clinical Research Unit - Austin /ID# 248854

Austin, Texas, United States

Outcomes

Primary Outcomes

Maximum Plasma Concentration (Cmax)

Cmax will be assessed.

Time frame: Up to Day 52

Time to maximum observed plasma concentration (Tmax)

Tmax will be assessed.

Time frame: Up to Day 52

Apparent terminal phase elimination rate constant (BETA or β)

Apparent terminal phase elimination rate constant (BETA or β) will be assessed.

Time frame: Up to Day 52

Mean terminal phase elimination half-life (t1/2)

T1/2 will be assessed.

Time frame: Up to Day 52

Area under the plasma curve (AUC)

AUC will be assessed.

Time frame: Up to Day 52

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.

Time frame: Up to Day 82

Data from ClinicalTrials.gov

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