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

Healthy Volunteers Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530278
• Other study ID #: M20-974
• Status: Completed
• Phase: Phase 1
• Start date: September 20, 2022
• Est. completion date: November 29, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Healthy Volunteers

Intervention

Drug:
• Galicaftor
Oral
• ABBV-576
Oral
• Navocaftor
Oral
• Midazolam
Oral

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 248824	Anaheim	California
United States	PPD Clinical Research Unit - Austin /ID# 248854	Austin	Texas
United States	PPD Clinical Research Unit -Las Vegas /ID# 248853	Las Vegas	Nevada
United States	Clinical Pharmacology of Miami /ID# 248823	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)	Cmax will be assessed.	Up to Day 52
Primary	Time to maximum observed plasma concentration (Tmax)	Tmax will be assessed.	Up to Day 52
Primary	Apparent terminal phase elimination rate constant (BETA or ß)	Apparent terminal phase elimination rate constant (BETA or ß) will be assessed.	Up to Day 52
Primary	Mean terminal phase elimination half-life (t1/2)	T1/2 will be assessed.	Up to Day 52
Primary	Area under the plasma curve (AUC)	AUC will be assessed.	Up to Day 52
Primary	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.	Up to Day 82