A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male... | NCT01684891

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

NCT01684891

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

6Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

RG1662

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-001434-34	EudraCT Number

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Sep 11, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Label	Type	Description	Intervention Names
RG1662	Experimental		Drug: RG1662

Name	Type	Description	Arm Group Labels	Other Names
RG1662	Drug	multiple doses of RG1662	RG1662

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided