Ph1 Study of Valortim and Ciprofloxacin in Humans

NCT00964561 | Suspended Phase 1 DMC

• 2 other identifiers: #0036-08-05NIAID #08-0053
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human subjects.

Conditions

Anthrax

Outcome Measures

Primary Outcomes (1)

• Determination of changes from baseline for clinical laboratory tests and urinalysis, blood pressure, heart rate, respiratory rate, body temperature, physical examination and ECG

  134 days

Secondary Outcomes (1)

• Evaluation of PK parameters for IV administration of ciprofloxacin when dosed concomitantly with Valortim

  134 days

Study Arms (3)

Ciprofloxacin and Valortim

EXPERIMENTAL

First two subjects to receive treatment arm of Ciprofloxacin and Valortim. Total of sixteen volunteers to be randomized to receive Ciprofloxacin and Valortim.

Drug: Ciprofloxacin and Valortim

Placebo Antibiotic and Valortim

EXPERIMENTAL

Randomized such that four subjects to receive Placebo Antibiotic and Valortim.

Drug: Placebo Antibiotic and Valortim

Placebo Antibiotic and Placebo Valortim

EXPERIMENTAL

Randomized such that 4 subjects to receive Placebo Antibiotic and Placebo Valortim.

Other: Placebo Antibiotic and Placebo Valortim

Interventions

Ciprofloxacin and Valortim DRUG

Days 1-3 400mg IV Ciprofloxacin BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.

Also known as: MDX-1303

Ciprofloxacin and Valortim

Placebo Antibiotic and Valortim DRUG

Days 1-3 20mg/kg IV Normal Saline BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.

Also known as: MDX-1303

Placebo Antibiotic and Valortim

Placebo Antibiotic and Placebo Valortim OTHER

Days 1-3 200mL IV Normal Saline for Placebo Antibiotic over 60 minutes. Day 4 200mL IV Normal Saline for Placebo Valortim over 60 minutes.

Also known as: Saline

Placebo Antibiotic and Placebo Valortim

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Normal male or female subjects 18 to 59 years of age on Day -1 of the study
• Subject must have read, understood, and provided written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures
• In the opinion of the Investigator, subjects should be in generally good health, based upon prestudy medical history, physical examination, ECG and laboratory tests
• Laboratory screening values (i.e., hematology, clinical chemistries and urinalysis tests) must be within study-defined ranges
• No detectable antibody to B. anthracis Protective Antigen (PA-IgG) as measured by ELISA testing at study Screening
• Women of childbearing potential may be enrolled if one of the following criteria applies:
• Must be using an effective form of contraception (e.g., oral contraceptives, vaginal ring, IUD, injected or implanted hormonal contraception, double barrier method of condom and spermicide, diaphragm with spermicide or sponge with spermicide) for at least one month prior to study entry, must have maintained a normal menstrual pattern for the three months prior to study entry and have a negative pregnancy test at the time of admission to the unit. Women must be willing to continue this contraception throughout the course of the study.
• Is sexually abstinent
• Is monogamous with a vasectomized partner (\> 3 months prior)
• Is postmenopausal (i.e., no cycle for at least the previous 12 months, is of menopausal age (\> 45 years) and has a negative urine pregnancy test prior to enrollment into the study and a negative serum pregnancy test on Day -1)
• Is surgically sterilized (confirmed by medical record review)
• Has had a total hysterectomy a minimum of 3 months prior to dosing on Day 1 (confirmed by medical record review)
• Sexually active male subjects may be enrolled if one of the following criteria applies:
• Has had a vasectomy (\> 3 months prior to study entry, confirmed by medical record review)
• Using condoms and whose partner is using an acceptable form of contraception (IUD, oral contraceptives, birth control patch or vaginal ring, injectable or implanted contraceptives, or tubal ligation \[surgical sterilization\]) for the duration of the study

You may not qualify if:

• Prior known or suspected exposure to B. anthracis
• Prior vaccination for B. anthracis
• Any participants in the original FTIH study of Valortim.
• History of drug or alcohol abuse i.e. having been treated either in an in-patient or out-patient facility within 12 months of study Screening
• Positive drug result and/or positive alcohol result at time of study Screening or at Day -1
• Smoke more than 10 cigarettes per day for the last 6 months
• Treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) of study Screening
• Use of systemic immunosuppressive agents within 12 months of study Screening. Individuals who have received prednisone or its equivalent in doses of less than 20 mg/day for 14 days or less, as long as it occurred more than 1 month prior to them entering the study and as long as there is no clinical or laboratory evidence of immunosuppression, may be considered for enrollment
• Use of NSAIDs within 24 hours prior to dosing
• History of asthma requiring any use of inhaled or oral medication within the previous 5 years
• History of renal impairment
• History of central nervous system reactivity to any quinolone
• Any factor known to increase the risk of tendinitis or tendon rupture when taking a fluoroquinolone, including age older than 59 years; organ transplantation; use of systemic steroids (see number 7)
• Clinically significant medical or psychiatric condition that, in the opinion of the Investigator, may impair study participation to include ongoing recent illness, new medications prescribed in the previous 6 weeks or use of immunosuppressive agents
• Electrocardiogram with evidence of clinically significant conduction abnormalities or active ischemia (as determined by the Principal Investigator) at the time of study screening

Sponsors & Collaborators

• PharmAthene, Inc.: lead
• National Institutes of Health (NIH): collaborator
• Medarex: collaborator
• Quintiles, Inc.: collaborator
• Department of Health and Human Services: collaborator

Study Sites (1)

Quintiles Phase I Services

Overland Park, Kansas, 66211, United States

Location

Related Links

• Go to this website for more information about this study.

MeSH Terms

Conditions

Anthrax

Interventions

Ciprofloxacin; Sodium Chloride

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ralph A. Schutz, M.D.

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 22, 2009
• First Posted: August 25, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 10, 2010

Record last verified: 2009-08

Locations

US (1)