Your session is about to expire
← Back to Search
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
Awards & highlights
Study 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Altavant Sciences GmbHLead Sponsor
5 Previous Clinical Trials
190 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,955 Total Patients Enrolled
Thomas Hunt, MDPrincipal InvestigatorPPD
1 Previous Clinical Trials
52 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger