NCT01235871

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

November 2, 2010

Last Update Submit

April 19, 2012

Conditions

Healthy Volunteer

Keywords

SafetyTolerabilitySB1578

Outcome Measures

Primary Outcomes (1)

  • Assess number of participants with adverse events as a measure of safety and tolerability

    312 hours postdose

Secondary Outcomes (4)

  • Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve

    Predose to 312 hours postdose

  • Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5

    Predose, 6 and 24 hours postdose

  • Assess food effects on pharmacokinetics

    Predose to 312 hours postdose

  • Determine recommended dose

    March 2011

Study Arms (2)

SB1578

EXPERIMENTAL
Drug: SB1578

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SB1578DRUG

JAK2 Inhibitor

SB1578
PlaceboDRUG

Control arm

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History or presence of significant disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

15-(2-(pyrrolidin-1-yl)ethoxy)-7,12,25-trioxa-19,21,24-triazatetracyclo(18.3.1.1(2,5).1(14,18))hexacosa-1(24),2,4,9,14(26),15,17,20,22-nonaene

Study Officials

  • Mark J Allison, MD

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 8, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

US(1)