This study is an exploratory proof of mechanism (POM) study using PET/functional magnetic resonance imaging (fMRI) in a 2-period, 2-sequence, crossover design. The aim of the study is to confirm the potential of Ralmitaront to decrease dopamine synthesis capacity (DSC) - as measured by levels of F-DOPA - in the striatum of participants with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
35
Participants were given a once 150 mg daily dose of Ralmitaront orally during the 14 day treatment period.
\[18 F\]-DOPA solution for injection is manufactured by the PET imaging centers according to specifications established for the tracer at the site. The injection will happen prior to the scan being done and will last for approximately 30 seconds.
Participants were given a daily dose of the placebo during the 14 day treatment period.
Parexel California Clinical Trials Medical Group
Glendale, California, United States
Collaborative Neuroscience Network Inc.
Torrance, California, United States
CBH Health
Gaithersburg, Maryland, United States
St Louis Clinical Trials
St Louis, Missouri, United States
Influx Rate Constant (Ki) Value of [18F]-DOPA in the Whole Striatum, as Measured Using [18F]-DOPA PET Imaging
Time frame: Baseline, and on Days 13-14 and Days 34-35
Bilateral Ventral Striatum Eigenvariates From the T-Contrast of Rewarded vs. Non-reward Expectation During the Monetary Incentive Delay (MID) Task, as Assessed Using fMRI
Time frame: Baseline, and on Days 13-14 and Days 34-35
Percentage of High Effort Choices Under Deterministic Reward Condition for High Reward in the Effort-Choice Benefit Task
Time frame: Baseline, and on Days 13-14 and Days 34-35
Mean Cerebral Blood Flow (CBF) in Different Brain Regions, as Measured by fMRI
Time frame: Baseline, and on Days 13-14 and Days 34-35
Bilateral Eigenvariate From Dorsolateral Prefrontal Regions Defined Based on the 2-back >0-back Contrast in the N-back Working Memory Task, as Assessed Using fMRI
Time frame: Baseline, and on Days 13-14 and Days 34-35
Incidence and Severity of Adverse Events (AEs)
Time frame: From first dose until 14 days after the last dose of study treatment (up to 49 days)
Incidence of Treatment Discontinuations Due to AEs
Time frame: From first dose until 14 days after the last dose of study treatment (up to 49 days)
Incidence of Vitals Sign Abnormalities (Resting and Orthostatic)
Time frame: From first dose until 14 days after the last dose of study treatment (up to 49 days)
Change From Baseline in ECG Intervals: PQ (PR), QRS, QT, RR and QTcF
Time frame: Baseline, Days 13-14, 21, 34-35, and during the follow-up visit (14-18 days after last dose)
Incidence of Laboratory Abnormalities, Based on Hematology, Clinical Chemistry, and Urinalysis Test Results
Time frame: From first dose until 14 days after the last dose of study treatment (up to 49 days)
Concentration of Ralmitaront and Ralmitaront-derived Metabolite(s) Per Time-point
Time frame: Days 2, 7, 13-14, 23, 28, 34-35, and during the follow up visit (14-18 days after last dose)
Area Under the Curve (AUCss) of Ralmitaront and Ralmitaront-derived Metabolite(s)
Time frame: Days 2, 7, 13-14, 23, 28, 34-35, and during the follow up visit (14-18 days after last dose)
Cmax of Ralmitaront and Ralmitaront-derived Metabolite(s)
Time frame: Days 2, 7, 13-14, 23, 28, 34-35, and during the follow up visit (14-18 days after last dose)
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