A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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trodusquemine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes