Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
NCT ID: NCT02808312
Last Updated: 2021-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2016-07-13
2018-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Mild Hepatic Impairment
Participants with mild hepatic impairment will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).
Cilofexor
Tablet(s) administered orally in a fed state on Day 1
Cohort 1: Normal Hepatic Function
Matched normal hepatic function participants to mild hepatic impairment participants will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).
Cilofexor
Tablet(s) administered orally in a fed state on Day 1
Cohort 2: Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).
Cilofexor
Tablet(s) administered orally in a fed state on Day 1
Cohort 2: Normal Hepatic Function
Matched normal hepatic function participants to moderate hepatic impairment participants will receive a single oral dose of cilofexor 30 mg (3 x 10 mg tablets).
Cilofexor
Tablet(s) administered orally in a fed state on Day 1
Cohort 3: Severe Hepatic Impairment
Participants with severe hepatic impairment will receive a single oral dose of cilofexor 10 mg (1 x 10 mg tablet).
Cilofexor
Tablet(s) administered orally in a fed state on Day 1
Cohort 3: Normal Hepatic Function
Matched normal hepatic function participants to severe hepatic impairment participants will receive a single oral dose of cilofexor 10 mg (1 x 10 mg tablet).
Cilofexor
Tablet(s) administered orally in a fed state on Day 1
Interventions
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Cilofexor
Tablet(s) administered orally in a fed state on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals with mildly impaired and normal hepatic function.
* Individuals with mild hepatic impairment must have a score of 5-6 on the Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.
Cohort 2:
* Individuals with moderately impaired and normal hepatic function.
* Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.
Cohort 3:
* Individuals with severely impaired and normal hepatic function.
* Individuals with severe hepatic impairment must have a score of 10-15 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.
18 Years
ALL
Yes
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Miami, Florida, United States
Orlando, Florida, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States
Auckland, , New Zealand
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-402-3885
Identifier Type: -
Identifier Source: org_study_id
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