A PET Study With RO5545965 in Healthy Male Volunteers | NCT01923025

Studies
A PET Study With RO5545965 in Healthy Male Volunteers

NCT01923025

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

9Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

RO5545965

Countries

United Kingdom

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
2013-000538-36	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

Aug 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Aug 8, 2013

First Submission Date that Met QC Criteria

Aug 13, 2013

First Posted Date

Aug 14, 2013Estimated

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

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

9Actual

Label	Type	Description	Intervention Names
RO5545965	Experimental		Drug: RO5545965

Name	Type	Description	Arm Group Labels	Other Names
RO5545965	Drug	Single dose	RO5545965

Measure	Description	Time Frame
Pharmacodynamics: Brain PDE10 occupancy by RO5545965		up to Day 2
PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations		up to Day 2

Measure	Description	Time Frame
Safety: Incidence of adverse events		up to 12 days
Pharmacokinetics: Plasma concentrations of RO5545965		up to Day 5

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects, 25 to 50 years of age, inclusive; healthy status is defined by absence of evidence of any active or chronic disease
Body mass index (BMI) 18 to 30 kg/m2 inclusive
Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis
History of clinically significant hypersensitivity or allergic drug reactions
Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
Positive for hepatitis B, hepatitis C, or HIV infection
Evidence of significant cardiovascular disease or disorder
Participation in an investigational drug or device study within 3 months prior to first administration of the study drug or within 6 times the elimination half-life, whichever is longer
Previous inclusion in a research and/or medical protocol or any clinical procedures involving nuclear medicine, PET, occupational exposure to ionizing radiation or radiological investigations with significant exposure to radiation, excluding dental X-ray and common X-rays of chest or extremities
Subject has any condition that would prevent an MRI from accurately or safely being performed [eg, claustrophobia, cardiac pacemaker, metallic implants or clips]
Subject unable to lie on his back in the PET or MRI scanner for a period of 90 minutes
Contraindication for arterial cannulation
Unsuitable veins for repeated venipuncture

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders