A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

Human Proof of Concept Positron Emission Tomography Study to Investigate [11C]-RO5011232 as a Radiotracer for Brain mGlu5 Receptor Occupancy and to Investigate the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-state.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483469
• Other study ID #: BP27890
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2011
• Last updated: November 1, 2016
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III, positron emission tomography (PET) assessments of specific uptake of the radiotracer and whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part IV, subjects will receive RO4917523 orally daily for 14 days while receiving three single intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is up to 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male and female volunteers as determined by medical history, physical examination, 12-lead ECG, and routine clinical laboratory measurements

• Age 18 to 65 years inclusive

• Body mass index (BMI) between 18 to30 kg/m2 inclusive and body weight at least 50 kg

• Appropriate body size (less than 195 cm [6 feet and 5 inches]) in order to accommodate the whole body scanning

Exclusion Criteria:

• History of or presence of clinically significant psychiatric condition, as evaluated by a psychiatrist before enrolment

• History of head trauma with prolonged loss of consciousness (>10 minutes) or any neurological condition or a history of migraine headaches

• Contraindications to MRI procedures (Part I, III and IV)

• Subjects suffering from claustrophobia or who would be unable to undergo magnetic resonance imaging (MRI) or PET scanning

• Positive pregnancy test at screening or on any day preceding a PET scan

• Lactating women

• Positive for hepatitis B, hepatitis C or HIV infection

• Any history of alcohol or drug abuse within the last 6 months

• Regular smoker or nicotine user (>10 cigarettes per day)

• Participation in an investigational drug or device study within three months prior to screening

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917523
orally daily, 14 days
• RO5011232
[11C]-RO5011232 intravenously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part I: mGlu5 receptor binding of [11C]-RO5011232 radiotracer in human brain, assessed by positron emission tomography (PET)		approximately 6 months	No
Primary	Part II: Dosimetry/radiation safety of [11C]-RO5011232 assessments by whole body PET scan		approximately 6 months	No
Primary	Part III: Measurement of test-retest precision of PET images of regions of interest in the human brain		approximately 6 months	No
Primary	Part IV: Correlation between RO4917523 plasma concentration and R04917523 binding to mGlu5 receptor in brain		approximately 6 months	No
Secondary	Safety of [11C]-RO5011232 administered intravenously at microdose level: Incidence of adverse events		approximately 6 months	No
Secondary	Part IV: In vitro binding potential (reference region with no specific binding of radiotracer) assessed by PET		approximately 6 months	No
Secondary	Part IV: Safety of 14-day treatment with RO4917523: Incidence of adverse events		approximately 6 months	No