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

NCT01815827 | Completed Phase 1

• 1 other identifier: BP28134
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  up to 197 days

• Pharmacokinetics: Maximum plasma concentration (Cmax)

  up to 197 days

Secondary Outcomes (3)

• 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

  approximately 10 months

Study Arms (2)

Caucasian Healthy volunteers

ACTIVE COMPARATOR

Drug: inclacumab

Japanese Healthy volunteers

EXPERIMENTAL

Drug: inclacumab

Interventions

inclacumab DRUG

single intravenous doses

Caucasian Healthy volunteers; Japanese Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Anaheim, California, 92801, United States

Location

Related Publications (1)

• 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.

  PMID: 26363899 DERIVED

MeSH Terms

Interventions

inclacumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)