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Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01919125
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 6, 2013
First Posted Date  ICMJE August 8, 2013
Last Update Posted Date January 26, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
  • Maximum plasma concentration (Cmax) [ Time Frame: Up to 6 days ]
  • Time to maximum plasma concentration (Tmax) [ Time Frame: Up to 6 days ]
  • Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last) [ Time Frame: Up to 6 days ]
  • AUC from time zero to infinity (AUC0-~) [ Time Frame: Up to 6 days ]
  • AUC from time zero to 24 hours (AUC0-24h) [ Time Frame: Up to 6 days ]
  • Plasma concentration 24 hours after dosing (C24h) [ Time Frame: Up to 6 days ]
  • Apparent terminal elimination rate constant [ Time Frame: Up to 6 days ]
  • Observed terminal half-life (T1/2) [ Time Frame: Up to 6 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
PK Evaluation of IDX719 [ Time Frame: 6 days ]
PK measures of plasma drug exposure and elimination (AUC0-inf, Cmax, t1/2) of IDX719
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
  • Percentage of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to 6 days ]
  • Percentage of participants experiencing an adverse event (AE) [ Time Frame: Up to 6 days ]
  • Percentage of participants experiencing Grade 1-4 laboratory abnormalities [ Time Frame: Up to 6 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
Safety and Tolerability [ Time Frame: 6 days ]
Proportions of subjects experiencing adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)
Official Title  ICMJE A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
Brief Summary The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE Drug: IDX719
IDX719 supplied as 50 mg tablets.
Other Name: Samatasvir
Study Arms  ICMJE
  • Experimental: Cohort 1: Child-Pugh Class A
    Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
    Intervention: Drug: IDX719
  • Experimental: Cohort 2: Child-Pugh Class B
    Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
    Intervention: Drug: IDX719
  • Experimental: Cohort 3: Child-Pugh Class C
    Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
    Intervention: Drug: IDX719
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
  • All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
  • Male subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Other clinically significant medical conditions or laboratory abnormalities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01919125
Other Study ID Numbers  ICMJE 1894-008
IDX-06A -008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP