Status:
COMPLETED
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cysti...
Eligibility Criteria
Inclusion
- Key
- Parts A, B, and C:
- Female subjects must be of non-childbearing potential.
- Between the ages of 18 and 55 years, inclusive.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight \>50 kg
- Parts D, E, and F:
- Body weight ≥35 kg.
- Subjects must have an eligible CFTR genotype:
- Parts D and F: Heterozygous for F508del and an MF mutation (F/MF)
- Part E: Homozygous for F508del (F/F)
- FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.
- Key
Exclusion
- Parts A, B, and C:
- Any condition possibly affecting drug absorption.
- History of febrile illness within 14 days before the first study drug dose.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Parts D, E, and F:
- History of clinically significant cirrhosis with or without portal hypertension.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Lung infection with organisms associated with a more rapid decline in pulmonary status.
- History of solid organ or hematological transplantation.
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
January 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2018
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT03227471
Start Date
January 23 2017
End Date
March 27 2018
Last Update
January 18 2022
Active Locations (38)
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1
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Valley Children's Healthcare
Madera, California, United States, 93636
4
(Kaiser Permanente) Oakland Medical Center
Oakland, California, United States, 96411