Healthy VolunteerPhase 1NCT01579149
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
A Phase 1 study testing plerixafor in people with Healthy Volunteer, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- plerixafor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- plerixafor, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plerixaforDrug
Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg),
PlaceboDrug
Single subcutaneous (SC) dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| plerixafor | Experimental | Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg) Receives: Drug: plerixafor |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics as measured by maximum observed concentration (Cmax)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetics as measured by time to maximum concentration (Tmax)
Measured: 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
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetics as measured by terminal half-life (t1/2)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetics as measured by apparent volume of distribution (Vz/F)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetics as measured by apparent total systemic clearance (CL/F)
Measured: Pre-dose to 24 hours post-dose
Secondary outcomes (1)
Safety as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Measured: From the administration of study drug and up to 15 day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579149
- Sponsor's protocol ID
- MOZ24211
- Status last verified
- Mar 2015
- First submitted
- 13 Apr 2012
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01579149
- Acronym / sponsor ID
- MOZ24211
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plerixafor | Experimental | Drug: plerixaforSingle subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plerixaforSingle subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), | Drug | plerixafor |
| PlaceboSingle subcutaneous (SC) dose of placebo | Drug | Placebo |
Primary outcome
Pharmacokinetics as measured by maximum observed concentration (Cmax)
Time frame: 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
• 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
Pharmacokinetics as measured by terminal half-life (t1/2)
Time frame: 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
Pharmacokinetics as measured by apparent total systemic clearance (CL/F)
Time frame: Pre-dose to 24 hours post-dose
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing plerixafor in people with Healthy Volunteer, run by Genzyme, a Sanofi Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics as measured by maximum observed concentration (Cmax) (time frame: Pre-dose to 24 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.