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To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the pharmacokinetics of VX-661 when administered in combination with ivacaftor
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant ciprofloxacin. |
|
| Cohort 2 | Experimental | Participants in Cohort 2 will be administered VX-661 in combination with ivacaftor followed by VX-661 in combination with ivacaftor and concomitant ciprofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivacaftor | Drug |
| ||
| VX-661 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone | PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC), | Day 7, Day 14 |
| PK parameters of VX-661 and metabolites when dosed in combination with ivacaftor and concomitant ciprofloxacin relative to VX-661 administered in combination with ivacaftor | PK parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC), | Day 10, Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin | PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC), | Day 10, Day 20 |
| Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceutical Incorporated | Study Director |
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|
| ciprofloxacin | Drug |
|
| Day 1 through Day 21 (cohort 1) or Day 34 (cohort2) |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| C545203 | ivacaftor |
| C000625213 | tezacaftor |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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