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Serotonin Synthesis Inhibitor
Rodatristat ethyl for Healthy Subjects
Phase 1
Waitlist Available
Led By Thomas Hunt, MD
Research Sponsored by Altavant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 days
Summary
This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 11 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1 will evaluate the effect of a high-fat meal on the PK of rodatristat ethyl, rodatristat, and its metabolite(s) following single-dose administration of a rodatristat ethyl 600 mg dose
Part 2 will assess the PK of rodatristat ethyl, rodatristat, and metabolite(s) following multiple repeat doses of rodatristat ethyl at a supratherapeutic level
Secondary study objectives
Part 1 will also evaluate the effect of a high-fat meal on other PK parameters of rodatristat ethyl, rodatristat, and its metabolites
Part 2 will also assess the effect of a supratherapeutic dose of rodatristat ethyl on plasma 5 hydroxyindoleacetic acid (5 HIAA) concentrations
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rodatristat ethylExperimental Treatment1 Intervention
Part One: is 600 QD
Group II: PlaceboPlacebo Group2 Interventions
Part Two: Placebo match for Rodatristat ethyl
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rodatristat Ethyl
2023
Completed Phase 1
~70
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PPD DEVELOPMENT, LPIndustry Sponsor
158 Previous Clinical Trials
36,015 Total Patients Enrolled
Altavant Sciences GmbHLead Sponsor
5 Previous Clinical Trials
190 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,357 Total Patients Enrolled
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