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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01815827
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 7.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: inclacumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: An Open-label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Caucasian Healthy volunteers	Drug: inclacumab; single intravenous doses
Experimental: Japanese Healthy volunteers	Drug: inclacumab; single intravenous doses

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics: Area under the concentration-time curve (AUC) [up to 197 days]

2. Pharmacokinetics: Maximum plasma concentration (Cmax) [up to 197 days]

Secondary Outcome Measures

1. Pharmacodynamics: Blood platelet leukocytes aggregation (PLA) [up to 197 days]

2. Pharmacodynamics: Plasma (free and total) soluble P-selectin [up to 197 days]

3. Safety: Incidence of adverse events [approximately 10 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anaheim	California	United States	92801

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01815827
• Other Study ID Numbers: BP28134
• First Posted: Mar 21, 2013
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016