Clinical trial NCT01923025: A PET Study With RO5545965 in Healthy Male Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 9
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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).


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacodynamics: Brain PDE10 occupancy by RO5545965
timeFrame: up to Day 2
measure: PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations
timeFrame: up to Day 2
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to 12 days
measure: Pharmacokinetics: Plasma concentrations of RO5545965
timeFrame: up to Day 5
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: