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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
Healthy males or females aged 18 to 55 years, inclusive.
A male subject is eligible to participate if he does not have a female partner who is pregnant or who intends to become pregnant during the study. Male subjects must agree to use contraception starting at Screening, during the treatment period, and for at least 100 days after the last dose of study drug, and refrain from donating sperm during this period.
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 days for reporting.

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
159 Previous Clinical Trials
36,881 Total Patients Enrolled
Thomas Hunt, MDPrincipal InvestigatorPPD
1 Previous Clinical Trials
52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental protocol permit applicants aged 35 or older?

"This clinical trial has a participant age range of 18 to 55 years old. Separately, there are 51 trials for minors and 351 studies that focus on people over the retirement threshold."

Answered by AI

How does Rodatristat ethyl affect one's safety and wellbeing?

"The safety of Rodatristat ethyl is rated a 1, since this trial is in its initial stage and limited data exist to substantiate the drug's efficacy or security."

Answered by AI

Is participation in this clinical experiment an option for me?

"To meet the eligibility requirements of this trial, applicants should be within 18-55 years old and possess general good health. As such, 34 participants total are sought after for recruitment."

Answered by AI

Are there any unfilled positions available for participants in this research?

"Affirmative. Clinicaltrials.gov reports that this trial, which was initially posted on September 29th 2022, is actively seeking candidates to participate. In total, 34 individuals are required from 1 particular site."

Answered by AI

How many individuals are being monitored during this research endeavor?

"Affirmative. According to the information published on clinicaltrials.gov, this research is still in need of participants from a single medical centre with 34 patients needed all together. The study was first posted on September 29th 2022 and most recently revised on January 12th 2023."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety
2022. "A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05684640.
~14 spots leftby Apr 2025
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