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Multiple-Ascending Dose in Japanese Patients Bridging Study

NCT05065359 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-07-13

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Rodatristat Ethyl 300 mg BID

Tablets, oral, 300 mg, BID 14 days

DRUG

Rodatristat Ethyl 600 mg BID

Tablets, oral, 600 mg, BID 14 days

DRUG

Placebo

Tablets, oral, 0 mg, BID for 14 days

Sponsors & Collaborators

  • Altavant Sciences, Inc.

    collaborator UNKNOWN

  • Parexel

    collaborator INDUSTRY

  • Altavant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-03-30
Completion
2022-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065359 on ClinicalTrials.gov