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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2014

Interventions

  • Drug: inclacumab
    • single intravenous doses

Arms, Groups and Cohorts

  • Active Comparator: Caucasian Healthy volunteers
  • Experimental: Japanese Healthy volunteers

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)
    • Time Frame: up to 197 days
  • Pharmacodynamics: Plasma (free and total) soluble P-selectin
    • Time Frame: up to 197 days
  • Safety: Incidence of adverse events
    • Time Frame: approximately 10 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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