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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815827
• Other study ID #: BP28134
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2013
• Last updated: November 1, 2016
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• inclacumab
single intravenous doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration-time curve (AUC)		up to 197 days	No
Primary	Pharmacokinetics: Maximum plasma concentration (Cmax)		up to 197 days	No
Secondary	Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)		up to 197 days	No
Secondary	Pharmacodynamics: Plasma (free and total) soluble P-selectin		up to 197 days	No
Secondary	Safety: Incidence of adverse events		approximately 10 months	No