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A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects with Chronic Hepatitis C Genotype 1 Infection.

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects with Chronic Hepatitis C Genotype 1 Infection.

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs ALS 2158 (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions
  • Sponsors Alios BioPharma

Most Recent Events

  • 26 Sep 2012 Secondary endpoint 'Viral-kinetic-parameters' has not been met.
  • 30 Jul 2012 Results are expected by the end of 2012 according to a Vertex Pharmaceuticals media release.
  • 13 Mar 2012 Planned end date changed from 1 Jun 2012 to 1 Dec 2012 as reported by ClinicalTrials.gov.

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