Healthy
Conditions
Brief summary
An open label, 2-period, sequential study to determine the impact of multiple doses of ketoconazole on single-dose pharmacokinetics of HCV-796
Interventions
DRUGKetoconazole
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of multiple oral doses of ketoconazole on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of HCV-796 and ketoconazole when coadministered to healthy subjects. | — |
Outcome results
None listed