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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

Study Description
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Brief Summary:
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of SB1578 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: SB1578 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: SB1578 Drug: SB1578
JAK2 Inhibitor
Placebo Comparator: Placebo Drug: Placebo
Control arm


Outcome Measures
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Primary Outcome Measures :
  1. Assess number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 312 hours postdose ]

Secondary Outcome Measures :
  1. 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 ]
  2. Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5 [ Time Frame: Predose, 6 and 24 hours postdose ]
  3. Assess food effects on pharmacokinetics [ Time Frame: Predose to 312 hours postdose ]
  4. Determine recommended dose [ Time Frame: March 2011 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235871


Locations
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United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
S*BIO
Investigators
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Principal Investigator: Mark J Allison, MD Celerion
More Information
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Responsible Party: S*BIO
ClinicalTrials.gov Identifier: NCT01235871    
Other Study ID Numbers: SB1578-2010-001
First Posted: November 7, 2010    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012
Keywords provided by S*BIO:
Safety
Tolerability
SB1578