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

Healthy Volunteers Clinical Trial

— M23-492 FE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538585
• Other study ID #: M23-492
• Status: Completed
• Phase: Phase 1
• Start date: September 27, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: January 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 objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Galicaftor
Oral
• Navocaftor
Oral

Locations

Country	Name	City	State
United States	Acpru /Id# 249532	Grayslake	Illinois
United States	Clinical Pharmacology of Miami /ID# 249531	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 Observed Plasma Concentration (Cmax)	Cmax will be assessed.	Up to Day 4
Primary	Time to Cmax (peak time, Tmax)	Tmax will be assessed.	Up to Day 4
Primary	Terminal Elimination Half-life (t1/2)	Terminal elimination half-life (t1/2) will be assessed.	Up to Day 4
Primary	Area under the plasma curve (AUC)	AUC will be assessed.	Up to Day 4
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 38

External Links

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