A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 7/16/2013 |
| Start Date: | July 2013 |
| Contact: | Medical Monitor |
| Email: | medicalinfo@vrtx.com |
| Phone: | 617-341-6777 |
A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects
This study is designed to investigate the effect of food on the relative bioavailability of
2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet
formulations.
Inclusion Criteria:
- Healthy male and female subjects as defined in the protocol
- Subjects who weigh >50 kg at Screening
Exclusion Criteria:
- History of any illness or condition that might confound the results of the study or
pose an additional risk to the subject upon administration of study drug - Positive
for hepatitis B,C, or HIV
- Standard 12-lead ECG demonstrating QTc >450 msec for male subjects and >480 msec for
female subjects at the Screening Visit
- Abnormal renal function as defined in the protocol at Screening
- Forced expiratory volume in 1 second (FEV1) <80% predicted at the Screening Visit
- Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the
first dose of study drug
- Treatment with an investigational drug or device within 30 days or 5 half-lives
preceding the first dose of study drug
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