Clinical trial NCT01684891: A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration time curve (AUC)
timeFrame: Selected Days between 1 and 28
measure: Pharmacokinetics: maximum serum concentration
timeFrame: Selected Days between 1 and 28
measure: Pharmacokinetics: Clearance of 13C-RG1662
timeFrame: Days 1 and 28
measure: Pharmacokinetics: Bioavailability of 13C-RG1662
timeFrame: Days 1 and 28
Secondary outcomes:
measure: Amount of drug excreted in urine over the sampling interval
timeFrame: Days 1 to 15
measure: Amount of drug excreted in the feces over the sampling interval
timeFrame: Pre-dose, days 1 to 15
measure: Incidence of adverse events
timeFrame: Up to approximately 10 weeks
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: