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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-27

Study Completion Date

2022-12-21

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1: Navocaftor with food

Participants will receive navocaftor administered with food

Group Type EXPERIMENTAL

Navocaftor

Intervention Type DRUG

Oral

Part 1: Navocaftor without food

Participants will receive navocaftor administered without food

Group Type EXPERIMENTAL

Navocaftor

Intervention Type DRUG

Oral

Part 2: Galicaftor with food

Participants will receive galicaftor administered with food

Group Type EXPERIMENTAL

Galicaftor

Intervention Type DRUG

Oral

Part 2: Galicaftor without food

Participants will receive galicaftor administered without food

Group Type EXPERIMENTAL

Galicaftor

Intervention Type DRUG

Oral

Interventions

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Galicaftor

Oral

Intervention Type DRUG

Navocaftor

Oral

Intervention Type DRUG

Other Intervention Names

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ABBV-2222 ABBV-3067

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes