MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: tezacaftor/ivacaftor
Product Code: VX-661/VX-770
Pharmaceutical Form: Granules
INN or Proposed INN: Tezacaftor
CAS Number: 1152311-62-0
Current Sponsor code: VX-661
Concentration unit: m
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject will sign and date an informed consent form (ICF) 2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures 3. Subjects (male and female) between the ages of 19 and 55 years, inclusive, and healthy, as defined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination (PE), including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests 4. Body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive, and a total body weight >50 kg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of febrile illness or other acute illness within 5 days before the first study drug dose 2. Any condition possibly affecting drug absorption 3. History of, or positive screen for, hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) 4. History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject 5. Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the relative BA of a granule formulation of tezacaftor (TEZ)/ivacaftor (IVA) compared to a reference fixed-dose combination (FDC) tablet of TEZ/IVA;Secondary Objective: To evaluate the safety and tolerability of TEZ/IVA administered as granules;Primary end point(s): PK parameters of TEZ and IVA parent compounds, including Cmax, AUC0-8, and AUC0-tlast;Timepoint(s) of evaluation of this end point: - Day 1 and Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability as assessed by adverse events (AEs), clinical laboratory assessments, vital signs, and 12-lead ECGs ;Timepoint(s) of evaluation of this end point: - From Day 1 Through Day 31 | — |
Countries
United States
Contacts
Public ContactVertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Outcome results
None listed