Status:
COMPLETED
Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).
Eligibility Criteria
Inclusion
- Key
- Part A, B, and C: Healthy Volunteers
- 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
- Part D: Subjects with CF
- Heterozygous for F508del and an MF mutation (F/MF)
- FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
- Body weight ≥35 kg
- Key
Exclusion
- Part A, B and C: Healthy Volunteers
- Any condition possibly affecting drug absorption
- History of febrile illness or other acute illness within 5 days before the first study drug dose
- Part D: Subjects with CF
- History of clinically significant cirrhosis with or without portal hypertension
- History of solid organ or hematological transplantation
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2019
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03768089
Start Date
March 20 2018
End Date
May 3 2019
Last Update
July 14 2022
Active Locations (7)
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1
Academic Medical Center
Amsterdam, Netherlands
2
PRA Health Sciences Onderzoekscentrum UMCG
Groningen, Netherlands
3
UMC St. Radboud
Nijmegen, Netherlands
4
Erasmus Medical Center
Rotterdam, Netherlands