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

NCT05530278 | Completed Phase 1 FDA Drug

• 1 other identifier: M20-974
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy Volunteers

Keywords

Galicaftor; Navocaftor; ABBV-576; Cystic Fibrosis

Outcome Measures

Primary Outcomes (6)

• Maximum Plasma Concentration (Cmax)

  Cmax will be assessed.

  Up to Day 52

• Time to maximum observed plasma concentration (Tmax)

  Tmax will be assessed.

  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.

  Up to Day 52

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

  T1/2 will be assessed.

  Up to Day 52

• Area under the plasma curve (AUC)

  AUC will be assessed.

  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.

  Up to Day 82

Study Arms (5)

ABBV-576 with Galicaftor + Navocaftor

EXPERIMENTAL

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

Drug: Galicaftor; Drug: ABBV-576; Drug: Navocaftor

Navocaftor + Galicaftor with ABBV 576

EXPERIMENTAL

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

Drug: Galicaftor; Drug: ABBV-576; Drug: Navocaftor

Optional: Navocaftor with ABBV 576

EXPERIMENTAL

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

Drug: ABBV-576; Drug: Navocaftor

Optional: Galicaftor with ABBV 576

EXPERIMENTAL

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

Drug: Galicaftor; Drug: ABBV-576

Optional: Midazolam with ABBV-576 + Navocaftor

EXPERIMENTAL

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

Drug: ABBV-576; Drug: Navocaftor; Drug: Midazolam

Interventions

Galicaftor DRUG

Oral

ABBV-576 with Galicaftor + Navocaftor; Navocaftor + Galicaftor with ABBV 576; Optional: Galicaftor with ABBV 576

ABBV-576 DRUG

Oral

ABBV-576 with Galicaftor + Navocaftor; Navocaftor + Galicaftor with ABBV 576; Optional: Galicaftor with ABBV 576; Optional: Midazolam with ABBV-576 + Navocaftor; Optional: Navocaftor with ABBV 576

Navocaftor DRUG

Oral

ABBV-576 with Galicaftor + Navocaftor; Navocaftor + Galicaftor with ABBV 576; Optional: Midazolam with ABBV-576 + Navocaftor; Optional: Navocaftor with ABBV 576

Midazolam DRUG

Oral

Optional: Midazolam with ABBV-576 + Navocaftor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Anaheim Clinical Trials LLC /ID# 248824

Anaheim, California, 92801-2658, United States

Location

Clinical Pharmacology of Miami /ID# 248823

Miami, Florida, 33014, United States

Location

PPD Clinical Research Unit -Las Vegas /ID# 248853

Las Vegas, Nevada, 89113-2235, United States

Location

PPD Clinical Research Unit - Austin /ID# 248854

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 7, 2022
• Study Start: September 20, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)