Trial document

PLEASE NOTE:
This study has been imported from ClinicalTrials.gov without additional data checks.

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DRKS-ID: 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

DRKS-ID: DRKS00008818
Date of Registration in DRKS: 2015/08/12
Date of Registration in Partner Registry or other Primary Registry: 2015/03/25
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2015-000341-23
Primary Registry-ID: NCT02402452 (ClinicalTrials.gov)
Sponsor-ID: GS-US-338-1125 (Gilead Sciences)
Other Secondary-ID: 2015-000341-23

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Health Condition or Problem studied

Free text: HCV Infection
ICD10: B18 - Chronic viral hepatitis

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Interventions/Observational Groups

Arm 1: Drug: GS-9857

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Non-randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: [---]*
Purpose: Treatment
Assignment: Parallel
Phase: I
Off-label Drug use: [---]*

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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

US: United States
DE: Germany
NZ: New Zealand

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Locations of Recruitment

APEX GmbH, München

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Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2015/05/31
Target Sample Size: 20
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Gilead Sciences
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Gilead Sciences
- Luisa Stamm, MD, PhD
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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- Karim Sajwani
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- Telephone: [---]*
- Fax: [---]*
- E-mail: karim.sajwani at gilead.com
- URL: [---]*
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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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 .

Translation on version: 56
Last processed date by ClinicalTrials.gov: 2015/06/17

* This entry means the parameter is not applicable or has not been set.