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A Single and Multiple-Dose Study of SB1578

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: NCT01235871
Recruitment Status : Completed
First Posted : November 7, 2010
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
S*BIO

Tracking Information
First Submitted Date  ICMJE November 2, 2010
First Posted Date  ICMJE November 7, 2010
Last Update Posted Date April 20, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2010)		 Assess number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 312 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
  • Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve [ Time Frame: Predose to 312 hours postdose ]
  • Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5 [ Time Frame: Predose, 6 and 24 hours postdose ]
  • Assess food effects on pharmacokinetics [ Time Frame: Predose to 312 hours postdose ]
  • Determine recommended dose [ Time Frame: March 2011 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
  • Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve [ Time Frame: Predose to 312 hours postdose ]
  • Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5 [ Time Frame: Predose, 6 and 24 hours postdose ]
  • Assess food effects on pharmacokinteics [ Time Frame: Predose to 312 hours postdose ]
  • Determine recommended dose [ Time Frame: March 2011 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single and Multiple-Dose Study of SB1578
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SB1578 When Administered Orally to Healthy Adult Subjects With One Single-Dose Group Crossing Over to Assess Food Effect
Brief Summary The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of SB1578 in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: SB1578
    JAK2 Inhibitor
  • Drug: Placebo
    Control arm
Study Arms  ICMJE
  • Experimental: SB1578
    Intervention: Drug: SB1578
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2012)		 40
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2010)		 64
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive).
  • Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55 and 100 kg (inclusive).
  • Medically healthy with clinically insignificant screening results.

Exclusion Criteria:

  • History or presence of significant disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT01235871
Other Study ID Numbers  ICMJE SB1578-2010-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party S*BIO
Original Responsible Party Joy Zhu, MD, PhD, Sr. Vice President, Global Clinical Development, S*BIO
Current Study Sponsor  ICMJE S*BIO
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark J Allison, MD Celerion
PRS Account S*BIO
Verification Date April 2012

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