A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
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This is a single-center, open label, multiple dose study to investigate the pharmacokinetics of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male volunteers. The anticipated time of study treatment is 4 weeks.
Single-center, Open Label, Multiple Dose Study to Investigate the Pharmacokinetics of RG1662 Given BID Over 28 Days, and in Addition, the Excretion and Metabolism of [13C]-Labelled IV Microdoses and an Oral [14C]-Labelled Dose of RG1662 in Healthy Male Volunteers
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Layout table for eligibility information
Ages Eligible for Study:
30 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male volunteers
Volunteers who are surgically sterilized or who do not intend to father children in the future
Absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
Body mass index (BMI) between 18 and 30 kg/m2 inclusive
Volunteers and their partners of childbearing potential must use two medically approved methods of contraception (e.g. hormonal contraception, IUD, barrier contraception), one of which must be a barrier method, for the duration of the study and for 3 months after last drug administration
If capable of reproduction, unwilling to use an effective form of contraception
Suspicion of regular consumption of drug of abuse
Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2
Clinically relevant ECG abnormalities at screening
Family history of congenital long QT syndrome or known congenital arrhythmia
Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg. Resting Pulse Rate greater than 90 or less than 45 beats per minute
Any other clinical relevant clinical abnormalities
Participation in an investigational drug or device study within 90 days prior to screening
Donation of more than 500 mL of blood within three months prior to screening
Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the volunteer in this study