A Pharmacokinetic Evaluation Study in Healthy Volunteers

Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00210054

Enrollment

Registered

2005-09-21

Start date

2002-11-30

Completion date

2002-12-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.

Interventions

DRUGdenufosol tetrasodium (INS37217)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Inclusion criteria

* are nonsmokers or those subjects whom have not smoked within 6 months * are within 20% of their ideal body weight * are healthy on the basis of a pre-trial physical examination

Exclusion criteria

* history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening * history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy * use of concomitant medication other than hormonal contraceptives and multi-vitamins * donation of blood in the 60 days preceding the screening visit * have been diagnosed with HIV, hepatitis B or hepatitis C

Design outcomes

Primary

Measure	Time frame
detection and characterization of plasma concentrations of INS37217	—

Secondary

Measure	Time frame
Pilot study - not specified	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026