A Study of Single Dose Inclacumab in Japanese Healthy Vol... | NCT01815827

Studies
A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers

NCT01815827

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

62Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

inclacumab

Countries

United States

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

Nov 2016

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

Jun 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 19, 2013

First Submission Date that Met QC Criteria

Mar 19, 2013

First Posted Date

Mar 21, 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

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.

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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Caucasian Healthy volunteers	Active Comparator		Drug: inclacumab
Japanese Healthy volunteers	Experimental		Drug: inclacumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inclacumab	Drug	single intravenous doses	Caucasian Healthy volunteers Japanese Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics: Area under the concentration-time curve (AUC)		up to 197 days
Pharmacokinetics: Maximum plasma concentration (Cmax)		up to 197 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)		up to 197 days
Pharmacodynamics: Plasma (free and total) soluble P-selectin		up to 197 days
Safety: Incidence of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
Japanese subjects must have Japanese parents and grandparents who were born in Japan
Caucasian subjects must have Caucasian parents and grandparents
Body mass index (BMI) 18 - 30 kg/m2 inclusive

Exclusion Criteria:

Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs
Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)
Smokes more than 5 cigarettes per day during the three months prior to study conduct
Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening
Positive test for drugs of abuse
Any suspicion of or history of alcohol and/or other substance abuse or addiction
Pregnant or lactating women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Anaheim	California	92801	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26363899	Derived	Morrison M, Palermo G, Schmitt C. Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2015 Nov;71(11):1365-74. doi: 10.1007/s00228-015-1938-4. Epub 2015 Sep 12.