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 (ABBV-576 DDI)

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Navocaftor; Drug: ABBV-576; Drug: Midazolam; Drug: Galicaftor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05530278

M20-974

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 main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

ABBV-576 with Galicaftor + Navocaftor

Experimental group

Description:

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

Treatment:

Drug: Navocaftor

Drug: Galicaftor

Drug: ABBV-576

Navocaftor + Galicaftor with ABBV 576

Experimental group

Description:

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

Treatment:

Drug: Navocaftor

Drug: Galicaftor

Drug: ABBV-576

Optional: Navocaftor with ABBV 576

Experimental group

Description:

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

Treatment:

Drug: Navocaftor

Drug: ABBV-576

Optional: Galicaftor with ABBV 576

Experimental group

Description:

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

Treatment:

Drug: Galicaftor

Drug: ABBV-576

Optional: Midazolam with ABBV-576 + Navocaftor

Experimental group

Description:

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

Treatment:

Drug: Navocaftor

Drug: ABBV-576

Drug: Midazolam