NCT00509132

Brief Summary

The purpose of this study is to evaluate the safety and tolerance of single intravenous (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine. Finally, this study will also determine whether trodusquemine has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started May 2007

Shorter than P25 for phase_1 obesity

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

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 9, 2008

Status Verified

January 1, 2008

Enrollment Period

5 months

First QC Date

July 27, 2007

Last Update Submit

January 8, 2008

Conditions

Obesity

Interventions

trodusquemineDRUG

Eligibility Criteria

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

You may qualify if:

  • male or female subjects, between 18 and 55 years old (inclusive);
  • body mass index (BMI) of 27-40 kg/m2;

You may not qualify if:

  • likely allergy or sensitivity to any components of Trodusquemine for Injection based on known allergies to drugs of the same class, or which, in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity to trodusquemine HCl;
  • any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
  • any subject with a history of severe allergy or bronchial asthma;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles, Inc.

Overland Park, Kansas, 66283, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

3-N-1(spermine)-7, 24-dihydroxy-5-cholestane 24-sulfate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Phil Leese, MD

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 31, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 9, 2008

Record last verified: 2008-01

Locations

US(1)