NCT00896974

Brief Summary

This research study is looking at 9cUAB30 in healthy participants. Studying samples of blood and urine from healthy participants may help doctors learn more about how 9cUAB30 is used by the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2008

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, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 18, 2015

Status Verified

February 1, 2014

Enrollment Period

1.6 years

First QC Date

May 9, 2009

Last Update Submit

June 17, 2015

Conditions

No Evidence of Disease

Outcome Measures

Primary Outcomes (1)

  • Single dose pharmacokinetics of 9cUAB30

    Scatterplots will be used to explore possible associations. Jonckheere-Terpstra trend test will be performed to determine the significance of the association between increasing dose level and each of the pharmacokinetic parameters. A Spearman rank correlation analysis will be performed to determine the relationship between actual dose administered and the pharmacokinetic parameters. Additionally, logistic regression analyses will be performed to correlate PK parameters with toxicity.

    0, 30, 45, 60, and 90 minutes, 2, 4, 6, 8, 12, 16, 18, 20, and 24 hours, and day 8

Secondary Outcomes (1)

  • Grade II or greater toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Up to 30 days

Study Arms (1)

Arm I

EXPERIMENTAL

Participants receive a single dose of oral 9cUAB30 on day 1.

Other: Laboratory Biomarker AnalysisOther: Pharmacological StudyDrug: Retinoid 9cUAB30

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I
Pharmacological StudyOTHER

Correlative studies

Arm I
Retinoid 9cUAB30DRUG

Given orally

Also known as: 9cUAB30
Arm I

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer
  • Karnofsky performance status (PS) 70-100% (ECOG PS 0-1)
  • WBC ≥ 3,000/mm³
  • Platelet count ≥ 100,000mm³
  • Hemoglobin \> 10 g/dL
  • Bilirubin ≤ 1.4 mg/dL
  • AST ≤ 1.5 times normal
  • Creatinine normal
  • Sodium 135-144 mmol/L
  • Potassium 3.2-4.8 mmol/L
  • Chloride 85-114 mmol/L
  • Bicarbonate \> 11 mEQ/dL
  • Fasting triglycerides ≤ 1.5 times upper limit of normal (ULN)
  • Fasting cholesterol ≤ 1.5 times ULN
  • Not pregnant or nursing
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

UAB 30

Study Officials

  • Howard Bailey

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 18, 2015

Record last verified: 2014-02

Locations

US(1)