Study Assessing Single and Multiple Doses of IDX21459 in... | NCT02112942

Studies
Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

NCT02112942

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Jan 26, 2016Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Chronic Hepatitis C

Interventions

IDX21459
Matching Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IDX-04C-001

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Early termination of IDX21459 was due to integration of Merck's HCV antiviral pipeline has resulted in revisions of the clinical development plan.

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 10, 2014

First Submission Date that Met QC Criteria

Apr 10, 2014

First Posted Date

Apr 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days	Drug: IDX21459 Drug: Matching Placebo
Group B	Experimental	HCV subjects genotype 1, IDX21459 capsules, once for 1 day	Drug: IDX21459
Group C	Experimental	HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days	Drug: IDX21459 Drug: Matching Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IDX21459	Drug		Group A Group B Group C
Matching Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability assessment	Proportion of subjects experiencing adverse events.	up to 35 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic	Plasma and urine concentrations of IDX21459 and its metabolite/s.	Up to 120 hours post dose

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 without cirrhosis.
Treatment-naïve
HCV Genotype 1

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided