A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
NCT ID: NCT01684891
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2012-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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RG1662
RG1662
multiple doses of RG1662
Interventions
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RG1662
multiple doses of RG1662
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
55 Years
MALE
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Zuidlaren, , Netherlands
Countries
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Other Identifiers
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2012-001434-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WP28214
Identifier Type: -
Identifier Source: org_study_id