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A PET Study With RO5545965 in Healthy Male Volunteers

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01923025
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
3
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Single Centre, Open Label Study to Characterize the PK-PDE10A Enzyme Occupancy Relationship of RO5545965 After a Single Dose in Healthy Male Volunteers Using [11C]IMA107 Positron Emission Tomography
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: RO5545965

Drug: RO5545965
Single dose

Outcome Measures

Primary Outcome Measures

  1. Pharmacodynamics: Brain PDE10 occupancy by RO5545965 [up to Day 2]

  2. PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations [up to Day 2]

Secondary Outcome Measures

  1. Safety: Incidence of adverse events [up to 12 days]

  2. Pharmacokinetics: Plasma concentrations of RO5545965 [up to Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 London United Kingdom NW10 7EW

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01923025
Other Study ID Numbers:
  • BP28844
  • 2013-000538-36
First Posted:
Aug 14, 2013
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of Nov 2, 2016