NCT05538585

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

September 12, 2022

Last Update Submit

January 12, 2023

Conditions

Healthy Volunteers

Keywords

GalicaftorNavicaftorABBV-3067ABBV-2222

Outcome Measures

Primary Outcomes (5)

  • Maximum Observed Plasma Concentration (Cmax)

    Cmax will be assessed.

    Up to Day 4

  • Time to Cmax (peak time, Tmax)

    Tmax will be assessed.

    Up to Day 4

  • Terminal Elimination Half-life (t1/2)

    Terminal elimination half-life (t1/2) will be assessed.

    Up to Day 4

  • Area under the plasma curve (AUC)

    AUC will be assessed.

    Up to Day 4

  • 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

Study Arms (4)

Part 1: Navocaftor with food

EXPERIMENTAL

Participants will receive navocaftor administered with food

Drug: Navocaftor

Part 1: Navocaftor without food

EXPERIMENTAL

Participants will receive navocaftor administered without food

Drug: Navocaftor

Part 2: Galicaftor with food

EXPERIMENTAL

Participants will receive galicaftor administered with food

Drug: Galicaftor

Part 2: Galicaftor without food

EXPERIMENTAL

Participants will receive galicaftor administered without food

Drug: Galicaftor

Interventions

GalicaftorDRUG

Oral

Also known as: ABBV-2222
Part 2: Galicaftor with foodPart 2: Galicaftor without food
NavocaftorDRUG

Oral

Also known as: ABBV-3067
Part 1: Navocaftor with foodPart 1: Navocaftor without food

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Pharmacology of Miami /ID# 249531

Miami, Florida, 33014, United States

Location

Acpru /Id# 249532

Grayslake, Illinois, 60030, United States

Location

Related Links

MeSH Terms

Interventions

GLPG2222

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 14, 2022

Study Start

September 27, 2022

Primary Completion

December 21, 2022

Study Completion

December 21, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)