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Trial record 2 of 10 for:    X4P

A Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02680782
Recruitment Status : Terminated
First Posted : February 12, 2016
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
X4 Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 12, 2016
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE January 12, 2016
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • Incidence of treatment emergent adverse events (safety and tolerability) in subjects administered X4P-001 200 mg twice daily compared with 400 mg once daily. [ Time Frame: Up to 14 to 21 days post-last dose ]
    Safety assessments include ongoing monitoring of adverse events, ongoing monitoring of concomitant medications and regulatory scheduled vital signs, physical examinations and laboratory tests (hematology, clinical chemistry, urinalysis and coagulation).
  • Maximum Plasma Concentration (Cmax) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily. [ Time Frame: Up to 48 hours post-dose ]
    Cmax data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
  • Area under the curve (AUC) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily. [ Time Frame: Up to 48 hours post-dose ]
    AUC data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
  • Minimum Plasma Concentration (Cmin) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily. [ Time Frame: Up to 48 hours post-dose ]
    Amin data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • To assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating white blood cells (total and by cell type). [ Time Frame: Up to 48 hours post-dose ]
    Whole blood samples will be obtained for PD studies concurrently with the PK samples. PD will be assessed via complete blood counts (CBC) with differential.
  • To assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating mononuclear cell phenotypes by cell surface markers. [ Time Frame: Up to 48 hours post-dose ]
    Whole blood samples will be obtained for PD studies concurrently with the PK samples. PD will be assessed via complete blood counts (CBC) with differential.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers
Official Title  ICMJE A Phase 1 Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers
Brief Summary

This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.

This study will also assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating white blood cells (total and by cell type).

Detailed Description This study will be conducted in 15 healthy volunteers at a clinical research unit located in Daytona Beach, Florida. Screening will be done within 35 days prior to the first dose of study drug (first Dosing Period). Each subject will complete two 10-day Dosing Periods, one using once daily dosing and the other twice daily dosing. The interval between the Dosing Periods will be 7 to 17 days. Patients will be randomly assigned to which regimen is administered the first Dosing Period. Safety laboratory tests will be performed at screening, and prior to and after each Dosing Period. End-of-Study (EOS) visit, the final study event, will be performed 14 to 21 days after the last dose of study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: X4P-001
100 mg capsules, administered orally for 10 days either as 200 mg BID or 400 mg QD. Subjects will be randomized to determine if they will receive the drug QD or BID in the first dosing period.
Other Name: AMD11070
Study Arms  ICMJE
  • Experimental: X4P-001 QD
    Subjects will receive study drug in two dosing periods. In this arm subjects will receive drug once daily in the first period, followed by twice daily in the second dosing period.
    Intervention: Drug: X4P-001
  • Experimental: X4P-001 BID
    Subjects will receive study drug in two dosing periods. In this arm subjects will receive drug twice daily in the first period, followed by once daily in the second dosing period.
    Intervention: Drug: X4P-001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 8, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2016
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Between 18 and 65 years of age, inclusive.
  2. Have signed the current approved informed consent form.
  3. For women of childbearing potential, (a) agree to use effective contraceptive methods from screening, through the study, and for at least 4 weeks after the last dose of study drug; and (b) have a negative pregnancy test (serum or urine) at screening and on Day -1 prior to each Dosing period.
  4. For men, agree both to (a) use effective contraceptive methods and (b) abstain from donating sperm, from admission to the in-residence unit prior to the first Dosing Period, through the study, and for at least 4 weeks after the last dose of study drug.
  5. Be willing and able to comply with this protocol.

Exclusion Criteria:

  1. Is an employee of the Phase 1 unit or an immediate family member of an employee.
  2. Has a BMI <18.0 or >30.0.
  3. Has a history of hypersensitivity or allergy to any drug compound, food or other substance assessed as significant by the Investigator.
  4. Has a history or presence of any medical condition capable of altering absorption, metabolism or elimination of drugs (history of routine cholecystectomy is permitted).
  5. Has alcohol intake exceeding 21 units per week for males or 14 units per week for females, where 1 unit = 12 oz (360 mL) beer, 5 oz (150 mL) wine, or 1.5 oz (45 mL) distilled spirits.
  6. Has within the past 12 months used illicit drugs.
  7. Has within the past 6 months been a smoker or used tobacco or nicotine replacement products.
  8. Is within 6 months post-partum or termination of a pregnancy.
  9. Has within the past 30 days or 5 half-lives, whichever is longer, participated in any other clinical trial involving an investigational treatment.
  10. Has within the past 30 days had an acute medical illness, including an active infection.
  11. Has within the past 30 days donated more than 500 mL of blood.
  12. Has within the past 30 days, or is scheduled to have while participating in the study, surgery requiring general anesthesia.
  13. Has within the past 30 days, or is scheduled to have while participating in the study, any immunizations.
  14. Has within the past 14 days been nursing.
  15. Has within the past 14 days donated plasma.
  16. Has within the past 14 days used any prescription or over the counter medications, unless deemed acceptable by the Investigator.
  17. Has positive urine or serum test for drugs of abuse or for cotinine.
  18. Has positive serologic laboratory tests:

    • Human immunodeficiency virus (HIV-1 or -2)
    • Hepatitis C virus (HCV)
    • Hepatitis B virus (HBV)
  19. Has confirmed abnormal safety laboratory tests representing CTCAE Grade 2 or higher. Subjects with Grade 1 abnormalities may be enrolled with the approval of the Investigator and the Sponsor.
  20. Has insufficient venous access to permit the scheduled blood sampling.
  21. Has any other medical or personal condition or finding that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the subject, or may preclude the subject's successful completion of the clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02680782
Other Study ID Numbers  ICMJE X4P-001-REGA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party X4 Pharmaceuticals
Study Sponsor  ICMJE X4 Pharmaceuticals
Collaborators  ICMJE Covance
Investigators  ICMJE
Study Director: Lu Gan, MD, PhD X4 Pharmaceuticals, Inc.
PRS Account X4 Pharmaceuticals
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP