A PET Study With RO5545965 in Healthy Male Volunteers

NCT01923025 | Completed Phase 1

• 2 other identifiers: BP288442013-000538-36
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Safety: Incidence of adverse events

  up to 12 days

• Pharmacokinetics: Plasma concentrations of RO5545965

  up to Day 5

Study Arms (1)

RO5545965

EXPERIMENTAL

Drug: RO5545965

Interventions

RO5545965 DRUG

Single dose

RO5545965

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 14, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)