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The objectives of this study are to evaluate the effects of VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-770 | Experimental |
| |
| Midazolam | Experimental |
| |
| Rosiglitazone | Experimental |
| |
| Fluconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-770 | Drug | In period 1, subjects will receive a single oral dose of midazolam (2 mg) and on Day 1 and Day 8. Subjects will receive single oral dose of rosiglitazone 4 mg and on Day2 and Day 9. Subjects will receive multiple doses of VX-770 150 mg q12h Day 3-10. |
| Measure | Description | Time Frame |
|---|---|---|
| Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter | 11 days | |
| Fluconazole and VX 770 PK parameters | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 1´ hydroxy midazolam PK parameters in plasma | 11 days | |
| Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments | 21 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Frank Farmer, MD | Covance CRU, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covan CRU, Inc. | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C545203 | ivacaftor |
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| VX-770 | Drug | In period 2, subjects will receive 150 mg VX-770 q12h orally from Day 1 through the morning of Day 8. On the morning of Period 2 Day 1, subjects will receive a 400 mg loading dose of fluconazole. Thereafter, subjects will receive 200 mg fluconazole qd orally from Day 2 through Day 9. |
|
| Metabolites PK parameters in plasma |
| 21 days |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |