London, NW10 7EW, United Kingdom
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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Notify MeKey information
Age range
25 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugSingle dose
Primary outcomes
-
Pharmacodynamics: Brain PDE10 occupancy by RO5545965
Time frame: up to Day 2
-
PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations
Time frame: up to Day 2
Secondary outcomes
-
Safety: Incidence of adverse events
Time frame: up to 12 days
-
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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