This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
- Incidence, severity and duration of nausea and vomiting collected as adverse events.
Time frame: Day 1 to day 28
- Change in body weight from baseline
Time frame: Day 1 to day 28
- Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline
Time frame: Day 1 to day 28
- Multiple dose PK parameters of PF 05212389
Time frame: Day 1 to day 28
- Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason
Time frame: Day 1 to day 28
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QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts