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A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers

NCT02512562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-10-16

No results posted yet for this study

Summary

This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and Simeprevir on AL-335 pharmacokinetics in healthy volunteers.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

AL-335

AL-335 is a prodrug being developed as an orally administered anti-HCV therapeutic.

DRUG

ACH-3102

ACH-3102 is an NS5A inhibitor being developed as an orally administered anti-HCV therapeutic.

DRUG

Simeprevir

Simeprevir is an orally active, small molecule inhibitor of the NS3/4A protease of HCV and indicated for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Alios Biopharma Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • France

Study Locations

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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 NCT02512562 on ClinicalTrials.gov