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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684891
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RG1662 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: RG1662 Drug: RG1662
multiple doses of RG1662

Primary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration time curve (AUC) [ Time Frame: Selected Days between 1 and 28 ]
  2. Pharmacokinetics: maximum serum concentration [ Time Frame: Selected Days between 1 and 28 ]
  3. Pharmacokinetics: Clearance of 13C-RG1662 [ Time Frame: Days 1 and 28 ]
  4. Pharmacokinetics: Bioavailability of 13C-RG1662 [ Time Frame: Days 1 and 28 ]

Secondary Outcome Measures :
  1. Amount of drug excreted in urine over the sampling interval [ Time Frame: Days 1 to 15 ]
  2. Amount of drug excreted in the feces over the sampling interval [ Time Frame: Pre-dose, days 1 to 15 ]
  3. Incidence of adverse events [ Time Frame: Up to approximately 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684891

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

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Responsible Party: Hoffmann-La Roche Identifier: NCT01684891    
Other Study ID Numbers: WP28214
2012-001434-34 ( EudraCT Number )
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016