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0.9% Chloride

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 24, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

0.9% Chloride · 1 trial · 1 indication

Phase 1 1
NCT01287793Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy SubjectsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Healthy
NCT0128779348
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Study Endpoints

Primary Endpoints

Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses
Up to 96 hours

Secondary Endpoints

QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods
-2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Maximum concentration pharmacokinetic endpoint for tigecycline
-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Time of maximum concentration pharmacokinetic endpoint for tigecycline
-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
high dose tigecyclineEXPERIMENTAL -
regular dose tigecyclineEXPERIMENTAL -
moxifloxacinACTIVE_COMPARATOR -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
tigecyclineDRUGintravenous, 200 mg, single dose
moxifloxacinDRUGoral tablet, 400 mg, single dose
100 mL 0.9% Sodium Chloride intravenousDRUGintravenous fluid, 100 mL, single dose
placeboDRUG0.9% Sodium Chloride intravenous 100mL, single dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy * Body mass index 17.5 - 30.5 kg * Total body weight greater than 50 kg Exclusion Criteria: * Recent history of diarrhea * Use of oral antibiotics in the last 2 weeks * History of risk factors for QT prolongation pregnant females * Nursing females

Countries:United States
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Frequently asked questions about 0.9% Chloride

What is 0.9% Chloride?

0.9% Chloride is a small molecule drug being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and it is not yet approved for any indication.

What is 0.9% Chloride used for?

0.9% Chloride is being investigated for use in healthy individuals. It is currently in Phase 1 clinical trials, and its potential therapeutic application has not been established. The drug is not approved for any medical condition.

Who makes 0.9% Chloride?

0.9% Chloride is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is 0.9% Chloride in?

0.9% Chloride is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety and effects.

What clinical trials is 0.9% Chloride in?

0.9% Chloride has one completed clinical trial, NCT01287793, which evaluated the effect of single intravenous doses of tigecycline on QTc intervals in healthy subjects. The trial enrolled 48 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is 0.9% Chloride the same as tigecycline?

0.9% Chloride is the drug name used in the clinical trial NCT01287793, which studied the effect of tigecycline on QTc intervals. The trial used 0.9% Chloride as a control or diluent, and the investigational drug was tigecycline. The relationship between the two is specific to this trial context.