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

NCT01684891 | Completed Phase 1

• 2 other identifiers: WP282142012-001434-34
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• 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

• Pharmacokinetics: Bioavailability of 13C-RG1662

  Days 1 and 28

Secondary Outcomes (3)

• 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

Study Arms (1)

RG1662

EXPERIMENTAL

Drug: RG1662

Interventions

RG1662 DRUG

multiple doses of RG1662

RG1662

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)