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Completed

NCT Number: NCT01923025

A PET Study With RO5545965 in Healthy Male Volunteers

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).

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Key information

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5545965

Drug

Single dose

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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