MedTrace Logo

Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242

NCT02824666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-07-17

No results posted yet for this study

Summary

This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using \[18F\] Fallypride PET in up to three cohorts of subjects.

Conditions

Interventions

DRUG

ATI-9242

Formulated ATI-9242 will be administered as an IV bolus injection (2mg/mL of ATI-9242 in 40% solution of propylene glycol). Two doses will be tested: single IV bolus injection of 0.5mg/kg and single IV bolus injection 1.0 mg/kg. In the event that a third cohort is needed the IV bolus injection would be 2.0 mg/kg

RADIATION

[18F]Fallypride Imaging

Subjects will be injected with approximately 250 MBq or 6.75 mCi of \[18F\]Fallypride \[5-6 mCi being the typical range of injected dose\].

Sponsors & Collaborators

  • Braeburn Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-20
Primary Completion
2016-09-06
Completion
2016-11-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02824666 on ClinicalTrials.gov