Pharmacokinetics Study of NI-071 | NCT01931189

Studies
Pharmacokinetics Study of NI-071

NCT01931189

Sponsor

Nichi-Iko Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 30, 2014Estimated

Enrollment

96Actual

Phase

Phase 1

Conditions

Healthy

Interventions

NI-071
Infliximab

Countries

Japan

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

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Aug 26, 2013

First Submission Date that Met QC Criteria

Aug 26, 2013

First Posted Date

Aug 29, 2013Estimated

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

Jun 27, 2014

Last Update Posted Date

Jun 30, 2014Estimated

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

The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers

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

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NI-071	Experimental		Biological: NI-071
Infliximab	Active Comparator		Biological: Infliximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NI-071	Biological	100mg/vial	NI-071
Infliximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)		8 weeks
Safety : Incidence of Adverse Events		8 weeks
Safety : Incidence of Anti-Drug Antibodies(ADA)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.)
Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg

Exclusion Criteria:

Subjects with a following past History or concomitant diseases
- Chronic or recurrent infectious disease
- Demyelinating disease
- Congestive heart failure
- lymphoproliferative disorder or myelodysplastic syndrome
- Malignancy
- Interstitial lung disease
Subjects with active or latent tuberculosis or history of tuberculosis

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NichiIko Investigational Site		Tokyo			Japan

Intervention Browse Module

MeSH Terms

ID	Term
D000069285	Infliximab

Ancestor Terms

ID	Term
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided