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Clinical Trials

MainTitle

Pharmacokinetics of GS-9883 in Adults With Normal and Impaired Renal Function

This study has been completed
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02400307

First received: March 17, 2015
Last updated: September 18, 2015
Last Verified: September 2015
History of Changes
Purpose

Purpose

This study will evaluate the pharmacokinetic (PK) profile, safety, and tolerability of oral GS-9883 in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2)] with a participant in the control group.

Condition Intervention Phase
HIV

Drug : GS-9883
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of GS-9883 in Subjects With Normal and Impaired Renal Function

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Area under the concentration-time curve extrapolated to infinite time (AUCinf) for GS-9883 [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 ]
  • Area under the concentration-time curve from zero to the last quantifiable concentration (AUC_0-last) for GS-9883 [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 ]
  • Maximum observed plasma concentration (Cmax) of GS-9883 [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1 ]
Secondary Outcome Measures:
  • Incidence of treatment-emergent adverse events (AEs) and treatment-emergent laboratory abnormalities [ Time Frame: Up to 31 days ]

Enrollment: 18
Study Start Date: April 2015
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Severe Renal Impairment
Participants with severe renal impairment and matched healthy controls will receive a single dose of GS-9883.
Drug: GS-9883

GS-9883 75 mg tablet administered orally

Experimental: Moderate Renal Impairment
Participants with moderate renal impairment and matched healthy controls will receive a single dose of GS-9883.
Drug: GS-9883

GS-9883 75 mg tablet administered orally

Experimental: Mild Renal Impairment
Participants with mild renal impairment and matched healthy controls will receive a single dose of GS-9883.
Drug: GS-9883

GS-9883 75 mg tablet administered orally

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 79 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  • All Individuals:
    • Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening
  • Individuals with impaired renal function
    • Chronic stable renal impairment without recent clinical change
      • Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min
      • Moderate: CrCl = 30 - 59 mL/min
      • Severe: CrCl = 15 - 29 mL/min
  • Healthy individuals
    • CrCl ≥ 90 mL/min


    Exclusion Criteria:
  • All Individuals:
    • Pregnant or lactating females
    • HIV positive or chronic hepatitis B infected
  • Individuals with impaired renal function
    • Chronic liver disease
    • Dialysis or anticipated use of dialysis
    • Renal transplant

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02400307

Locations

United States, Florida
Avail Clinical Research
DeLand, Florida, United States, 32720
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
Prism Clinical Research
St. Paul, Minnesota, United States, 55114
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
New Zealand
Auckland Clinical Studies Limited
Grafton, Auckland, New Zealand, 1010
Christchurch Clinical Studies Trust
Christchurch, New Zealand, 8011

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Devi SenGupta, MD Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02400307   History of Changes  
Other Study ID Numbers: GS-US-141-1479  
  2015-000898-12  
Study First Received: March 17, 2015  
Last Updated: September 18, 2015  

Keywords provided by Gilead Sciences:

Phase 1
Renally Impaired

Additional relevant MeSH terms:
Renal Insufficiency

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.