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NCT Number: NCT00664625

A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronically infected with HCV genotype 1
  • Treatment naive or treatment non-responders or treatment intolerant
  • HCV RNA viral load of ≥10*5* IU/mL
  • BMI 18 to 35 kg/m²

Exclusion criteria

  • Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
  • Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
  • Co-infection with HIV or HBV

Treatment and study plan

BMS-791325

Drug

Capsules, Oral, Once Daily, Single Dose

Placebo

Drug

Capsules, Oral, Once Daily, Single Dose

Primary outcomes

  1. Safety Outcome Measures

    Time frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose

Secondary outcomes

  1. Pharmacokinetic Measures

    Time frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose

  2. Pharmacodynamic Measures

    Time frame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-791325 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 23, 2008
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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