A PET Study With RO5545965 in Healthy Male Volunteers

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923025
• Other study ID #: BP28844
• Secondary ID: 2013-000538-36
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2013
• Last updated: November 1, 2016
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• RO5545965
Single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics: Brain PDE10 occupancy by RO5545965		up to Day 2	No
Primary	PK/PD: Brain PDE10 inhibition in relationship to RO5545965 plasma concentrations		up to Day 2	No
Secondary	Safety: Incidence of adverse events		up to 12 days	No
Secondary	Pharmacokinetics: Plasma concentrations of RO5545965		up to Day 5	No