A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RG1662

• Registration Number: NCT01684891
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RG1662	RG1662	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Bioavailability of 13C-RG1662	Days 1 and 28
Pharmacokinetics: Area under the concentration time curve (AUC)	Selected Days between 1 and 28
Pharmacokinetics: maximum serum concentration	Selected Days between 1 and 28
Pharmacokinetics: Clearance of 13C-RG1662	Days 1 and 28

Secondary Outcome Measures

Name	Time	Method
Amount of drug excreted in urine over the sampling interval	Days 1 to 15
Amount of drug excreted in the feces over the sampling interval	Pre-dose, days 1 to 15
Incidence of adverse events	Up to approximately 10 weeks