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Serotonin Synthesis Inhibitor

Rodatristat Ethyl 300 mg BID - Caucasian subjects for Healthy Subjects

Phase 1
Waitlist Available
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 21 days

Summary

This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of rodatristat ethyl by incidence of adverse events
Secondary study objectives
Pharmacodynamic assessment - change from baseline in 5-HIAA concentrations
Single dose AUC(0-t)
Single dose AUC(0-∞)
+9 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Rodatristat Ethyl 600 mg BID - Japanese subjectsExperimental Treatment1 Intervention
Group II: Rodatristat Ethyl 600 mg BID - Caucasian subjectsExperimental Treatment1 Intervention
Group III: Rodatristat Ethyl 300 mg BID - Japanese subjectsExperimental Treatment1 Intervention
Group IV: Rodatristat Ethyl 300 mg BID - Caucasian subjectsExperimental Treatment1 Intervention
Group V: Placebo match for Rodatristat Ethyl 300 mg BID - Caucasian subjectsPlacebo Group1 Intervention
Group VI: Placebo match for Rodatristat Ethyl 600 mg BID - Caucasian subjectsPlacebo Group1 Intervention
Group VII: Placebo match for Rodatristat Ethyl 300 mg BID - Japanese subjectsPlacebo Group1 Intervention
Group VIII: Placebo match for Rodatristat Ethyl 600 mg BID - Japanese subjectsPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rodatristat Ethyl 600 mg BID
2021
Completed Phase 1
~50
Rodatristat Ethyl 300 mg BID
2021
Completed Phase 1
~50

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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
177 Total Patients Enrolled
Altavant Sciences, Inc.UNKNOWN
2 Previous Clinical Trials
8 Total Patients Enrolled
ParexelIndustry Sponsor
311 Previous Clinical Trials
101,402 Total Patients Enrolled
~12 spots leftby Nov 2025
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