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History of Changes for Study: NCT01974687
Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects
Latest version (submitted September 12, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 28, 2013 None (earliest Version on record)
2 November 1, 2013 Recruitment Status, Study Status and Contacts/Locations
3 August 14, 2014 Study Status
4 January 12, 2015 Outcome Measures, Study Status, Contacts/Locations, Arms and Interventions, Study Identification, Eligibility, Study Design and Study Description
5 February 2, 2015 Study Status, Eligibility and Study Identification
6 February 11, 2015 Contacts/Locations and Study Status
7 April 15, 2015 Study Status
8 May 4, 2015 Arms and Interventions, Study Design, Study Status, Study Identification, Outcome Measures and Study Description
9 June 3, 2015 Contacts/Locations and Study Status
10 July 9, 2015 Study Status and Contacts/Locations
11 August 5, 2015 Study Status, Contacts/Locations and Arms and Interventions
12 September 7, 2015 Recruitment Status, Study Status and Contacts/Locations
13 September 11, 2015 Study Status
14 September 24, 2015 Recruitment Status, Study Status and Study Design
15 March 30, 2016 Study Status
16 May 18, 2017 Arms and Interventions, Study Status, Study Description and Study Identification
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Results Submission Events
17 September 12, 2018 Study Status, Outcome Measures, Arms and Interventions, Oversight, Results, IPDSharing, Study Description and Study Identification
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Study NCT01974687
Submitted Date:  October 28, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: IDX-04B-001
Brief Title: Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects
Official Title: A Phase I/IIa Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects
Secondary IDs: U1111-1149-5611 [Universal Trial Number (UTN)]
Open or close this module Study Status
Record Verification: October 2013
Overall Status: Not yet recruiting
Study Start: November 2013
Primary Completion: April 2014 [Anticipated]
Study Completion:
First Submitted: October 28, 2013
First Submitted that
Met QC Criteria:
October 28, 2013
First Posted: November 1, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 28, 2013
Last Update Posted: November 1, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: A multi-part study to evaluate the safety, tolerability and PK of IDX21437 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21437 will be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.
Detailed Description:
Open or close this module Conditions
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C virus
HCV
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 5
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 136 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group A
Healthy subjects, sequential dose escalation, IDX21437 capsules or Matching Placebo capsules, once daily, for 1 or 7 days
Drug: IDX21437Drug: Matching Placebo
Experimental: Group B
HCV subjects genotype 1, IDX21437 capsules, once for 1 day
Drug: IDX21437
Experimental: Group C
HCV subjects genotype 1, IDX21437 capsules or Matching Placebo capsules, once daily, for 7 days
Drug: IDX21437Drug: Matching Placebo
Experimental: Group D
HCV subjects genotypes 2 to 6, IDX21437 capsules, once daily, for 7 days
Drug: IDX21437
Experimental: Group E
HCV subject genotype 1, IDX21437 capsules, once daily, for 1 day or for 7 days
Drug: IDX21437
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety and tolerability assessment
[ Time Frame: up to 35 days ]

Proportion of subjects experiencing adverse events.
Secondary Outcome Measures:
1. Pharmacokinetic
[ Time Frame: Up to 120 hours post dose ]

Plasma and urine concentrations of IDX21437 and its metabolite/s.
Other Outcome Measures:
1. Antiviral activity
[ Time Frame: Up to 35 days ]

Change in plasma HCV RNA and emergence of resistance mutations
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

All subjects

  • Subjects are in good general health.
  • Subjects have provided written informed consent form.
  • 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.

HCV Subjects

  • Documented clinical history compatible with chronic hepatitis C.
  • Treatment-naïve
  • HCV Genotype 1, 2, 3, 4, 5 or 6

Exclusion Criteria:

All subjects

  • Pregnant or breastfeeding
  • Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
  • Decompensated liver disease
  • Other clinically significant medical conditions or laboratory abnormalities.
Open or close this module Contacts/Locations
Central Contact Person: John Z Sullivan-Bolyai, MD
Telephone: 877-433-6491
Email: clinicaltrials@idenix.com
Locations: Canada
Montreal, Canada
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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