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
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer||Drug: SB1578 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
|Placebo Comparator: Placebo||
- Assess number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 312 hours postdose ]
- 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 ]
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- History or presence of significant disease.
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
|United States, Arizona|
|Tempe, Arizona, United States, 85283|
|Principal Investigator:||Mark J Allison, MD||Celerion|
|Other Study ID Numbers:||
|First Posted:||November 7, 2010 Key Record Dates|
|Last Update Posted:||April 20, 2012|
|Last Verified:||April 2012|