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CompletedNCT01684891Updated Nov 2, 2016

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

A Phase 1 interventional study of RG1662 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in Netherlands. Open to male participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
30 Years to 55 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    RG1662

    Drug: RG1662

Interventions

  • DrugRG1662

    multiple doses of RG1662

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Zuidlaren, 9471 GP, Netherlands
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01684891
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 13, 2012
Start date
Sep 2012
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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