Cystic Fibrosis
Conditions
Interventions
Part A
An oral dose of 250 mg VX-770 or placebo twice daily on Day 1, an oral dose of
300 mg VX-770 or placebo twice daily on Day 2, an oral dose of 350 mg VX-770 or
placebo twice daily on Day 3, an
Sponsors
Vertex Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part A Male Age 18-45 Non-smoking;Part B Male and females Age 18-45 Non-smoking
Exclusion criteria
Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of the study. In case of donating any blood or significant loss of blood within 60 days of the start of drug dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A Safety and tolerability of VX 770 as measured by standard 12 lead electrocardiograms (ECGs), adverse events, physical examinations, vital signs, and clinically significant laboratory assessments. Part B Time-matched, baseline-adjusted, placebo-subtracted QTcF interval obtained from continuous 12-lead ECG recording. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A - PK parameters of VX 770 and metabolites M1 and M6 in plasma Part B - Time-matched, baseline-adjusted, placebo-subtracted QT interval obtained from continuous ECG recording - Time-matched, baseline-adjusted, placebo-subtracted QTcB interval obtained from continuous ECG recording - PK parameters of VX 770 and its metabolites in plasma - Safety of VX 770 as measured by standard 12 lead ECGs, adverse events, physical examinations, vital signs, and clinically significant laboratory assessments. | — |
Countries
Netherlands
Outcome results
None listed