An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.
- ...
- Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.
- Willing and able to comply with scheduled visits, treatment plan, study restrictions,laboratory tests, contraception guidelines, and other study procedures
Exclusion Criteria
- History of febrile illness within 5 days before the first study drug dose
- For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
- Inability to swallow capsules, or inadequate venous access.
- ...
- History of febrile illness within 5 days before the first study drug dose
- For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
- Inability to swallow capsules, or inadequate venous access.
- Any condition possibly affecting drug absorption
- History of any illness, clinical condition, or other factor that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- Abnormal renal function at screening
- A screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus 1 or 2 antibodies.
Summary
- Conditions
- Cystic Fibrosis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Inclusion Criteria
- Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.
- ...
- Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.
- Willing and able to comply with scheduled visits, treatment plan, study restrictions,laboratory tests, contraception guidelines, and other study procedures
Exclusion Criteria
- History of febrile illness within 5 days before the first study drug dose
- For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
- Inability to swallow capsules, or inadequate venous access.
- ...
- History of febrile illness within 5 days before the first study drug dose
- For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
- Inability to swallow capsules, or inadequate venous access.
- Any condition possibly affecting drug absorption
- History of any illness, clinical condition, or other factor that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- Abnormal renal function at screening
- A screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus 1 or 2 antibodies.
Tracking Information
- NCT #
- NCT02015507
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Monitor Vertex Pharmaceutical Incorporated