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CompletedNCT01923025Updated Nov 2, 2016

A PET Study With RO5545965 in Healthy Male Volunteers

A Phase 1 interventional study of RO5545965 in Schizophrenia, sponsored by Hoffmann-La Roche. Completed at 1 site in United Kingdom. Open to male participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
25 Years to 50 Years
Sex
Male
01

Study 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).

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 9 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    RO5545965

    Drug: RO5545965

Interventions

  • DrugRO5545965

    Single dose

06

What researchers measure

Primary outcomes

  1. Pharmacodynamics: Brain PDE10 occupancy by RO5545965

    Time frame: up to Day 2

  2. PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations

    Time frame: up to Day 2

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: up to 12 days

  2. Pharmacokinetics: Plasma concentrations of RO5545965

    Time frame: up to Day 5

07

Study locations

1 site
  • London, NW10 7EW, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01923025
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 14, 2013
Start date
Aug 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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