- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579149
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
March 19, 2015 updated by: Genzyme, a Sanofi Company
A Phase 1, Randomized, Single-center, Single-dose, Double-blind, Placebo-controlled Pharmacokinetic, Safety, and Pharmacodynamic Study of Subcutaneous Injection of 160 μg/kg, 240 μg/kg, and 400 μg/kg Plerixafor in Healthy Adult Volunteers of Japanese Descent
The primary objective is to assess the pharmacokinetics of 3 dose levels of plerixafor injection (160 μg/kg, 240 μg/kg, and 400 μg/kg) in healthy adult subjects of Japanese descent.
Three cohorts of subjects will be enrolled.
Approximately 8 subjects will be enrolled in each cohort, 6 subjects who will receive a single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), and 2 subjects who will receive a single SC dose of placebo.
The lowest dose-level cohort (plerixafor 160 μg/kg) will be fully enrolled first, followed by the next highest dose-level cohort (plerixafor 240 μg/kg), and finally the highest dose-level cohort (plerixafor 400 μg/kg), provided safety criteria for dose escalation are met.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Screening will occur within 28 days prior to dosing.
Dosing will occur on Day 1 of each cohort.
Subjects will remain at the study center from Day -1 until discharge approximately 24 hours after dosing (Day 2) for pharmacokinetic, safety, and pharmacodynamic assessments; however, all subjects who receive any investigational product, including any subjects who prematurely withdraw from the study, will remain at the study center for a minimum of 4 hours after dosing.
A 15-day follow-up visit will be conducted 15 to 20 days postdose.
The study will be considered completed for a subject at the time he/she completes the 15-day follow-up visit.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female subjects of Japanese descent, i.e., the subject was born in Japan and has lived outside of Japan for <10 years, and the subject's biological parents and grandparents are fully Japanese and were born in Japan.
- Subjects with body weight <95.0 kg if male, <85.0 kg if female, and <175% of ideal body weight (IDW)
- The subject has estimated creatinine clearance 50 mL/min or higher as determined by the Cockcroft-Gault formula.
- The subject's serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT]), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory normal limit. Other biochemistry, hematology, and urinalysis laboratory parameters must not exceed National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
- The subject is negative for HIV, active hepatitis B, and active hepatitis C.
- The subject refrained from consuming alcohol for 48 hours prior to Day 1 and agrees to refrain from alcohol consumption through discharge from the center and 24 hours prior to the follow-up visit (Day 15 [+5 days]).
- Female subjects of child-bearing potential and male subjects with partners of child-bearing potential agree to use an effective means of birth control while on study therapy and for a minimum of 1 month following final study visit. Effective birth control includes: (a) birth control pills, depot progesterone, or an intrauterine device plus one barrier method; or (b) 2 barrier methods. Effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For subjects using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known.
- The subject has given written informed consent prior to undertaking any study-related procedure.
Exclusion Criteria:
- History of clinically significant cardiac disorders, pulmonary disorders, malignancy, or other major medical issues that, in the view of the Investigator, renders the subject at high risk from treatment complications.
- Known allergy or sensitivity to plerixafor.
- Blood donation within 30 days prior to Day 1.
- Active infection, including unexplained fever (temperature >38.1ºC) or antibiotic and/or antiviral therapy within 7 days prior to Day 1.
- Abnormal electrocardiogram (ECG) with clinically significant conduction (heart block; or QTc >430 ms [males] or QTc >450 ms [females]) or rhythm disturbance (ventricular arrhythmias) within 1 year prior to Day 1 that, in the opinion of the Investigator, warrants exclusion of the subject from the study.
- History or known current alcohol, narcotic, or illicit drug abuse within the past 5 years.
- If female, pregnant (defined as positive serum β-HCG test) or lactating.
- Any medication, including over-the-counter medications and/or alternative medication (eg, dietary, herbal, botanical, or homeopathic supplements), within 7 days prior to Day 1, with the exception of hormonal birth control.
- Blood transfusion in the 30 days prior to Day 1.
- The subject does not tolerate venipuncture.
- In the opinion of the Investigator, subject is unable to adhere to the requirements of the study.
- The subject previously received investigational therapy within 4 weeks of Day 1 or within 6 weeks of Day 1 in the case of a long-acting agent (half-life >14 days) such as an antibody, is currently enrolled in another investigational protocol, or plans to receive any other investigational product at any time during the course of this study up to the time of the final follow-up visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Single subcutaneous (SC) dose of placebo
|
Experimental: plerixafor
Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg)
|
Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg),
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics as measured by maximum observed concentration (Cmax)
Time Frame: Pre-dose to 24 hours post-dose
|
Pre-dose to 24 hours post-dose
|
Pharmacokinetics as measured by time to maximum concentration (Tmax)
Time Frame: Pre-dose to 24 hours post-dose
|
Pre-dose to 24 hours post-dose
|
• Pharmacokinetics as measured by area under the concentration-time curve (AUC) from Time 0 to 24 hours post-dose
Time Frame: Pre-dose to 24 hours post-dose
|
Pre-dose to 24 hours post-dose
|
Pharmacokinetics as measured by terminal half-life (t1/2)
Time Frame: Pre-dose to 24 hours post-dose
|
Pre-dose to 24 hours post-dose
|
Pharmacokinetics as measured by apparent volume of distribution (Vz/F)
Time Frame: Pre-dose to 24 hours post-dose
|
Pre-dose to 24 hours post-dose
|
Pharmacokinetics as measured by apparent total systemic clearance (CL/F)
Time Frame: Pre-dose to 24 hours post-dose
|
Pre-dose to 24 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From the administration of study drug and up to 15 day follow-up visit
|
From the administration of study drug and up to 15 day follow-up visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
April 13, 2012
First Submitted That Met QC Criteria
April 13, 2012
First Posted (Estimate)
April 17, 2012
Study Record Updates
Last Update Posted (Estimate)
March 23, 2015
Last Update Submitted That Met QC Criteria
March 19, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOZ24211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteer
-
Calico Life Sciences LLCAbbVieRecruitingHealthy VolunteerUnited States
-
BiogenRecruiting
-
International Bio serviceNot yet recruiting
-
International Bio serviceNot yet recruiting
-
International Bio serviceNot yet recruiting
-
Angion Biomedica CorpQuotient SciencesNot yet recruitingHealthy VolunteerUnited States
-
University Hospital, ToursRecruitingNeurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults (PROSCEA)Healthy VolunteerFrance
-
BiogenCompleted
-
TeneoFour Inc.Novotech (Australia) Pty LimitedCompletedHealthy VolunteerAustralia
-
Spero TherapeuticsCompleted
Clinical Trials on plerixafor
-
National Heart, Lung, and Blood Institute (NHLBI)Completed
-
Stephen CoubanGenzyme, a Sanofi CompanyCompletedMalignant Lymphoma, Stem Cell TypeCanada
-
Kyowa Kirin Co., Ltd.CompletedMultiple Myeloma and Malignant LymphomaJapan
-
Genzyme, a Sanofi CompanySanofiCompletedNeuroblastoma | Brain Tumors | Ewing's Sarcoma/Soft Tissue SarcomaBelgium, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom
-
University Hospital, Clermont-FerrandCompletedChildren Cancer, Solid TumorFrance
-
University of WashingtonCompleted
-
SanofiCompletedAutologous Haematopoietic Stem Cell TransplantChina
-
National Institute of Allergy and Infectious Diseases...Lombardi Comprehensive Cancer CenterTerminated
-
Genzyme, a Sanofi CompanyCompletedRenal ImpairmentUnited States