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

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

2022-09-20

Study Completion Date

2022-11-29

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 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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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

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABBV-576 with Galicaftor + Navocaftor

Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.

Group Type EXPERIMENTAL

Galicaftor

Intervention Type DRUG

Oral

ABBV-576

Intervention Type DRUG

Oral

Navocaftor

Intervention Type DRUG

Oral

Navocaftor + Galicaftor with ABBV 576

Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.

Group Type EXPERIMENTAL

Galicaftor

Intervention Type DRUG

Oral

ABBV-576

Intervention Type DRUG

Oral

Navocaftor

Intervention Type DRUG

Oral

Optional: Navocaftor with ABBV 576

Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days.

Group Type EXPERIMENTAL

ABBV-576

Intervention Type DRUG

Oral

Navocaftor

Intervention Type DRUG

Oral

Optional: Galicaftor with ABBV 576

Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.

Group Type EXPERIMENTAL

Galicaftor

Intervention Type DRUG

Oral

ABBV-576

Intervention Type DRUG

Oral

Optional: Midazolam with ABBV-576 + Navocaftor

Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.

Group Type EXPERIMENTAL

ABBV-576

Intervention Type DRUG

Oral

Navocaftor

Intervention Type DRUG

Oral

Midazolam

Intervention Type DRUG

Oral

Interventions

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Galicaftor

Oral

Intervention Type DRUG

ABBV-576

Oral

Intervention Type DRUG

Navocaftor

Oral

Intervention Type DRUG

Midazolam

Oral

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes