A PET Study With RO5545965 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: RO5545965

• Registration Number: NCT01923025
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission tomography (PET).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RO5545965	RO5545965	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	up to 12 days
Pharmacokinetics: Plasma concentrations of RO5545965	up to Day 5