NCT00725803

Brief Summary

The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies how the body processes a drug), and initial activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Hepatitis C Virus (HCV) infection.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

July 29, 2008

Last Update Submit

June 11, 2014

Conditions

HCV Infection

Keywords

Hepatitis CHCVFibrosisApoptosisGS-9450

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Throughout 7 weeks (2 weeks on treatment and 5 weeks post-treatment)

Secondary Outcomes (3)

  • Plasma pharmacokinetic parameters of GS-9450 and metabolites

    17 days (through 72 hours after last dose)

  • Change from baseline in alanine aminotransferase (ALT) levels at Day 14

    Day 14

  • Change from baseline in noninvasive markers (including cytokeratin 18 fragments) indicative of hepatic apoptosis

    Through Week 5 (2 weeks on treatment and 3 weeks post-treatment)

Study Arms (4)

Cohort 1

EXPERIMENTAL

Subjects randomized 3:1 (active:placebo) to receive GS-9450 10 mg/day or placebo.

Drug: GS-9450Drug: GS-9450 Placebo

Cohort 2

EXPERIMENTAL

Subjects randomized 3:1 (active:placebo) to receive GS-9450 40 mg/day or placebo.

Drug: GS-9450Drug: GS-9450 Placebo

Cohort 3

EXPERIMENTAL

Subjects randomized 3:1 (active:placebo) to receive GS-9450 80 mg/day or placebo.

Drug: GS-9450Drug: GS-9450 Placebo

Cohort 4

EXPERIMENTAL

Subjects randomized 3:1 (active:placebo) to receive GS-9450 5 mg/day or placebo. Cohort may or may not be conducted pending blinded review of previous cohorts.

Drug: GS-9450Drug: GS-9450 Placebo

Interventions

GS-9450DRUG

GS-9450 capsules administered orally once daily

Cohort 1Cohort 2Cohort 3Cohort 4
GS-9450 PlaceboDRUG

Placebo to match GS-9450 administered orally once daily

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged from 18 to 65 years old, inclusive.
  • Willing and able to provide written, informed consent
  • Have a body mass index between 19 and 32 kg/m2, inclusive, at screening.
  • Have chronic hepatitis C infection of any genotype (and subtype).
  • Subjects must be previously treated with pegylated interferon (PEG) or interferon (INF) with or without ribavirin (RBV) and either did not achieve a sustained viral response (undetectable HCV RNA) six months after cessation of anti-viral therapy, or did not tolerate PEG or INF with or without RBV therapy. Subjects who have contraindications to receiving PEG or INF with or without RBV may also be eligible.
  • ALT \>/= 1.5 X but \< 10 X the upper limit of the normal range (ULN); aspartate aminotransferase (AST) \< 10 X ULN; platelets \>/= 75,000/mm3; total bilirubin \</= 1.5 X ULN; prothrombin time \</= 1.5 X ULN; albumin \>/= 3.0 g/dL; absolute neutrophil count \>/= 1,000 cells/mm3; and hemoglobin \>/= 10 g/dL
  • Creatinine clearance \>/= 70 mL/min
  • A female of non-childbearing potential who is documented as either surgically sterile or post-menopausal for \>/= 2 years.
  • Females \< 2 years post-menopausal are required to have follicle-stimulating hormone (FSH) level of \>/= 40 mIU/mL. If of child-bearing potential or FSH \< 40 mIU/mL, must:
  • have negative serum pregnancy test and a negative urine pregnancy test, and
  • agree to use an acceptable method of contraception during heterosexual intercourse during the study and for \>/= 30 days or one menstrual cycle (whichever is the longer) after last dose of study drug.
  • If male, agree to use an acceptable method of contraception during heterosexual intercourse during the study and for at least 3 months after the last dose of study drug.
  • Subjects should be in reasonably good health as determined by the Investigator.

You may not qualify if:

  • Pregnant or breast feeding women or women who may wish to become pregnant during the study or within 30 days of study drug administration.
  • Males who have partners planning to become pregnant within 30 days of study drug administration.
  • Males and females of reproductive potential who are unwilling to use effective method(s) of birth control for a minimum of 30 days after ingestion of study medication
  • Coinfection with hepatitis B virus (HBV) or HIV
  • Known liver disease of a non-HCV etiology
  • Pancreatitis
  • Autoimmune disease
  • History of malignancy
  • Ongoing alcohol abuse.
  • Recent significant infection or symptoms of infection
  • Evidence of hepatocellular carcinoma (e.g., a-fetoprotein \> 50 ng/mL or as indicated by recent ultrasound)
  • Decompensated liver disease OR history of clinical hepatic decompensation
  • Hb \< 10 g/dL
  • Absolute neutrophil count (ANC) \< 1,000 cells/mm3
  • Therapy with potentially hepatotoxic/cholestatic drugs.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Würzburg, Germany

Location

Unknown Facility

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Hepatitis CFibrosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Oldach, MD

    Gilead Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2008

Study Completion

March 1, 2009

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

DE(5)NL(1)US(5)