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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01684891
First received: September 11, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: RG1662
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area under the concentration time curve (AUC) [ Time Frame: Selected Days between 1 and 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum serum concentration [ Time Frame: Selected Days between 1 and 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Clearance of 13C-RG1662 [ Time Frame: Days 1 and 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Bioavailability of 13C-RG1662 [ Time Frame: Days 1 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of drug excreted in urine over the sampling interval [ Time Frame: Days 1 to 15 ] [ Designated as safety issue: No ]
  • Amount of drug excreted in the feces over the sampling interval [ Time Frame: Pre-dose, days 1 to 15 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Up to approximately 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RG1662 Drug: RG1662
multiple doses of RG1662

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684891

Locations
Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01684891     History of Changes
Other Study ID Numbers: WP28214, 2012-001434-34
Study First Received: September 11, 2012
Last Updated: April 7, 2014
Health Authority: The Netherlands: De Centrale Commissie Mensgebonden Onderzoek (CCMO)

ClinicalTrials.gov processed this record on April 14, 2014