Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008818

Trial Description

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Title

A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Renal Function and Severe Renal Impairment

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study will evaluate the pharmacokinetics, safety, and tolerability of GS-9857 in adults
with severe renal impairment and matched healthy control adults.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008818
  •   2015/08/12
  •   2015/03/25
  •   no
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Secondary IDs

  •   2015-000341-23 
  •   NCT02402452  (ClinicalTrials.gov)
  •   GS-US-338-1125  (Gilead Sciences)
  •   2015-000341-23 
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Health Condition or Problem studied

  •   HCV Infection
  •   B18 -  Chronic viral hepatitis
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Interventions/Observational Groups

  •   Drug: GS-9857
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   I
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Primary Outcome

- Area under the concentration versus time curve from time zero to the last quantifiable concentration (AUClast) for GS-9857; time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 1; AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
- Area under the concentration-time curve extrapolated to infinite time (AUCinf) for GS-9857; time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 1; AUCinf is defined as the concentration of drug extrapolated to infinite time.
- Maximum observed plasma concentration (Cmax) of GS-9857; time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 1

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Secondary Outcome

- Safety profile of GS-9857 as measured by incidence of adverse events and laboratory abnormalities; time frame: Up to 45 Days

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Countries of Recruitment

  •   United States
  •   Germany
  •   New Zealand
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Locations of Recruitment

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Recruitment

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  •   2015/05/31
  •   20
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   79   Years
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Additional Inclusion Criteria

- All individuals:

- Screening laboratory values within defined thresholds for group

- Use of two effective contraception methods if female of childbearing potential
or sexually active male

- For individuals with severe renal impairment:

- Stable chronic kidney disease

- Creatinine clearance (CLcr) < 30 mL/min

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Exclusion Criteria

- All individuals:

- Pregnant or nursing female or male with pregnant female partner

- Hepatitis B virus, hepatitis C virus (HCV) or HIV infection

- History of clinically significant illness or any other medical disorder that may
interfere with the individual's treatment, assessment or compliance with the
protocol

- For individuals with severe renal impairment:

- Anticipated to require dialysis within 90 days of study dosing

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Addresses

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    • Gilead Sciences
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    • Gilead Sciences
    • Luisa Stamm, MD, PhD 
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    • Karim Sajwani 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   56
  •   2015/06/17
* This entry means the parameter is not applicable or has not been set.