Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–55
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Males
Age 18- 55 years
Body mass index (BMI) 18.0 kg/m2 to 32.0 kg/m2
Body weight 55.0 kg to 100.0 kg
Considered to be in good health
Nonsmoker
Content of 14C in urine, whole blood, and/or plasma samples does not exceed the general environmental background level of 14C
You may not be if
Clinically significant abnormal medical history or any abnormal finding on physical examination, vital signs, ECG, laboratory tests
History of cancer that has not been in full remission for \>5 years
Acute illness within 14 days prior to Day 1
History of significant drug allergies
History or presence of alcohol or drug abuse
Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
Usual habit of \<1 or \>3 bowel movements per day
Exposure to radiation for therapeutic, diagnostic, or occupational reasons within the 12 months prior to Day 1.
Participation in another clinical study in which a \[14C\]-labeled drug was administered within 1 year prior to Check-in
Administration of another investigational medication within 60 days (or 5 half-lives, whichever is longer) prior to Day 1
Participation in an investigational-device study within 60 days prior to Day 1
Any ECG abnormality considered to be clinically significant by the Investigator
QTcF interval \>450 msec and QRS interval \>120 msec
Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
Documented congenital or acquired long QT syndrome
Presence of clinically significant hypertension
Presence of clinically significant hypotension
Loss or donation of more than 500 mL blood within 60 days prior to the Screening
Excessive consumption of alcohol
Use of any live vaccinations within 30 days
Use/consumption of food or drugs known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inducers or potent CYP3A4 inhibitors within 14 days or 5 half-lives, whichever is longer, prior to RV521 administration
