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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014