A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor (M23-492 FE)

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Navocaftor; Drug: Galicaftor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05538585

M23-492

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Part 1: Navocaftor with food

Experimental group

Description:

Participants will receive navocaftor administered with food

Treatment:

Drug: Navocaftor

Part 1: Navocaftor without food

Experimental group

Description:

Participants will receive navocaftor administered without food

Treatment:

Drug: Navocaftor

Part 2: Galicaftor with food

Experimental group

Description:

Participants will receive galicaftor administered with food

Treatment:

Drug: Galicaftor

Part 2: Galicaftor without food

Experimental group

Description:

Participants will receive galicaftor administered without food

Treatment:

Drug: Galicaftor