Rodatristat ethyl for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
PPD Development, Austin, TXHealthy SubjectsRodatristat Ethyl - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
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Study Summary

This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 11 Days

11 Days
Part 2 will also assess the effect of a supratherapeutic dose of rodatristat ethyl on plasma 5 hydroxyindoleacetic acid (5 HIAA) concentrations
Part 2 will assess the PK of rodatristat ethyl, rodatristat, and metabolite(s) following multiple repeat doses of rodatristat ethyl at a supratherapeutic level
6 Day
Part 1 will also evaluate the effect of a high-fat meal on other PK parameters of rodatristat ethyl, rodatristat, and its metabolites
6 Days
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

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Rodatristat ethyl
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

34 Total Participants · 2 Treatment Groups

Primary Treatment: Rodatristat ethyl · Has Placebo Group · Phase 1

Rodatristat ethyl
Drug
Experimental Group · 1 Intervention: Rodatristat Ethyl · Intervention Types: Drug
PlaceboPlaceboComparator Group · 2 Interventions: Rodatristat Ethyl, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rodatristat Ethyl
2022
Completed Phase 1
~40

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 11 days

Who is running the clinical trial?

Altavant Sciences GmbHLead Sponsor
4 Previous Clinical Trials
145 Total Patients Enrolled
PPDIndustry Sponsor
149 Previous Clinical Trials
32,054 Total Patients Enrolled
Thomas Hunt, MDPrincipal InvestigatorPPD
1 Previous Clinical Trials
52 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.