A Single and Multiple-Dose Study of SB1578

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S*BIO
ClinicalTrials.gov Identifier:
NCT01235871
First received: November 2, 2010
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Healthy Volunteer
Drug: SB1578
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by S*BIO:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5 [ Time Frame: Predose, 6 and 24 hours postdose ] [ Designated as safety issue: No ]
  • Assess food effects on pharmacokinetics [ Time Frame: Predose to 312 hours postdose ] [ Designated as safety issue: No ]
  • Determine recommended dose [ Time Frame: March 2011 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB1578 Drug: SB1578
JAK2 Inhibitor
Placebo Comparator: Placebo Drug: Placebo
Control arm

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235871

Locations
United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
S*BIO
Investigators
Principal Investigator: Mark J Allison, MD Celerion
  More Information

No publications provided

Responsible Party: S*BIO
ClinicalTrials.gov Identifier: NCT01235871     History of Changes
Other Study ID Numbers: SB1578-2010-001
Study First Received: November 2, 2010
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by S*BIO:
Safety
Tolerability
SB1578

ClinicalTrials.gov processed this record on April 22, 2014