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OpenTrials
Completed

NCT Number: NCT05538585

A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor

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 objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami /ID# 249531, Miami, Florida, United States

Loading trial locations.

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 <= 32.0 kg/ m2 after rounding to the tenth's 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 or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
  • Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Treatment and study plan

Galicaftor

Drug

Oral

Other names: ABBV-2222

Navocaftor

Drug

Oral

Other names: ABBV-3067

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 4

    Cmax will be assessed.

  2. Time to Cmax (peak time, Tmax)

    Time frame: Up to Day 4

    Tmax will be assessed.

  3. Terminal Elimination Half-life (t1/2)

    Time frame: Up to Day 4

    Terminal elimination half-life (t1/2) will be assessed.

  4. Area under the plasma curve (AUC)

    Time frame: Up to Day 4

    AUC will be assessed.

  5. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 38

    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

A Food-Effect Study for the Safety and Assessment of Pharmacokinetics of Navocaftor and Galicaftor.

Acronym: M23-492 FE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2022
Registry last updated
Jan 17, 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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