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Study to Evaluate Safety, PK and PD of Single and Multiple Ascending Doses of EP-7041 in Healthy Subjects

NCT02914353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-05-31

No results posted yet for this study

Summary

This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV administration of single ascending doses in healthy normal volunteers, and following continuous IV infusions of multiple ascending doses in healthy normal volunteers.

Conditions

  • Arthroplasty, Replacement, Knee

Interventions

DRUG

EP=7041

Factor X!a Inhibitor

DRUG

Placebo

Normal Saline

Sponsors & Collaborators

  • IDT CMAX Clinical Trials

    collaborator UNKNOWN

  • Syneos Health

    collaborator OTHER

  • CPR Pharma Services Pty Ltd, Australia

    collaborator INDUSTRY

  • eXIthera Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, MD · IDT CMAX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Companies

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 NCT02914353 on ClinicalTrials.gov