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OpenTrials
Completed

NCT Number: NCT05530278

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

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.

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Key information

Conditions

Healthy Volunteers Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials LLC /ID# 248824, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Galicaftor

Drug

Oral

ABBV-576

Drug

Oral

Navocaftor

Drug

Oral

midazolam

Drug

Oral

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Up to Day 52

    Cmax will be assessed.

  2. Time to maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 52

    Tmax will be assessed.

  3. Apparent terminal phase elimination rate constant (BETA or β)

    Time frame: Up to Day 52

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

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

    Time frame: Up to Day 52

    T1/2 will be assessed.

  5. Area under the plasma curve (AUC)

    Time frame: Up to Day 52

    AUC will be assessed.

  6. Number of Participants With Adverse Events (AEs)

    Time frame: Up to Day 82

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Acronym: ABBV-576 DDI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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