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AnthraxPhase 1NCT00964561

Ph1 Study of Valortim and Ciprofloxacin in Humans

A Phase 1 study testing Ciprofloxacin and Valortim in people with Anthrax, run by PharmAthene, Inc. at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Anthrax
What is being tested?
Ciprofloxacin and Valortim
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
Aug 2009to Jul 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
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  • 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
  • Is sexually abstinent
  • Female subjects must have a negative urine pregnancy test at study Screening and a negative serum pregnancy test on admission to the Phase I unit at Day -1
  • Female subject who are using injectable, transdermal, vaginal ring, oral contraceptives, or an IUD must agree to also use a barrier method (i.e. male condom, female condom, diaphragm, cervical cap) for the duration of their participation in the study.
  • Agreement to not receive any vaccinations from Day -1 through to 31 days post Valortim dosing. Vaccination against B. anthracis is prohibited during the study
  • Body Mass Index (BMI) ≥ 19 and ≤ 30
  • Abstinence from alcohol for 24 hours prior to study drug administration until discharge from the Phase I unit

Who cannot join

  • 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
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  • 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
  • Donation of one or more pints of blood 30 days prior to study Screening visit or donation prior to completion of Day 31 of the study
  • Donation of plasma within 14 days prior to study Screening visit or donation prior to completion of Day 31 of the study
  • Vaccinations within 30 days prior to Day -1 through to 31 days post Valortim dosing on Day 3
  • Prior known serum positivity for human immunodeficiency virus (HIV) antibodies, hepatitis B (surface antigen) or hepatitis C as determined at study Screening
  • Prior known allergy or allergic reaction to ciprofloxacin or any of the group of antibiotics known as quinolones
  • Diagnosis of photosensitivity, including, but not limited to, a history of phototoxic and/or photoallergic reactions to medications
  • Current treatment with, or use of, theophylline, methylxanthines, tizanidine, phenytoin, sulfonylurea glyburide, warfarin, probenecid, methotrexate, metoclopramide, corticosteroids and non-steroidal anti-inflammatory drugs
  • History of seizures, excluding pediatric febrile seizures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Quintiles Phase I Services

    Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: A Phase I, Single Blind, Randomized, Placebo Controlled, Drug Interaction Study of Intravenous (IV) Valortim® and Intravenous (IV) Ciprofloxacin in Healthy, Normal Subjects

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.

Read the detailed description

Valortim (MDX-1303) is a fully human monoclonal antibody (hmAb) with a high affinity for B. anthracis protective antigen (PA). Valortim is designed to target PA, which is one of three plasmid-encoded proteins that together form the toxins released by B. anthracis. Individually, these proteins (protective antigen (PA), lethal factor (LF) and edema factor (EF)) are inactive. Toxic effects require the transport of LF and EF into the host cell, mediated by the activity of PA. Valortim binds to PA and interferes with the activity of the toxins. Based on both non-clinical and clinical data, Valortim may have utility for the pre- and post-exposure prophylaxis of individuals exposed to, or at risk of exposure to, B. anthracis and for the treatment of individuals displaying signs or symptoms of inhalational anthrax. Because the treatment of inhalational anthrax includes the use of antibiotics such as fluoroquinolones, it is necessary to demonstrate that there are no adverse interactions between newer therapeutic interventions and these medications. The purpose of this study is to assess the safety and pharmacokinetics of ciprofloxacin (a commonly used fluoroquinolone for both treatment and post-exposure prophylaxis of anthrax) and Valortim following co-administration, as well as the safety and tolerability of these medications when administered concomitantly. These data are intended to support the use of Valortim as a treatment for inhalational anthrax.

Conditions
Anthrax
Being tested
Ciprofloxacin and Valortim, Placebo Antibiotic and Valortim, Placebo Antibiotic and Placebo Valortim
Medical subject headings
Anthrax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ciprofloxacin and ValortimDrug

    Also called MDX-1303

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

  • Placebo Antibiotic and ValortimDrug

    Also called MDX-1303

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

  • Placebo Antibiotic and Placebo ValortimOther

    Also called Saline

    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.

Study groups in NCT00964561
Study groupRoleWhat they receive
Ciprofloxacin and ValortimExperimentalFirst two subjects to receive treatment arm of Ciprofloxacin and Valortim. Total of sixteen volunteers to be randomized to receive Ciprofloxacin and Valortim.
Receives: Drug: Ciprofloxacin and Valortim
Placebo Antibiotic and ValortimExperimentalRandomized such that four subjects to receive Placebo Antibiotic and Valortim.
Receives: Drug: Placebo Antibiotic and Valortim
Placebo Antibiotic and Placebo ValortimExperimentalRandomized such that 4 subjects to receive Placebo Antibiotic and Placebo Valortim.
Receives: Other: Placebo Antibiotic and Placebo Valortim

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 134 days

Secondary outcomes (1)

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

    Measured: 134 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionFeb 2010 (estimated)
  4. Study completionJul 2010 (estimated)

Why it stopped: On partial hold for clinical investigation into AE and SAE reported.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00964561
Sponsor's protocol ID
#0036-08-05
Other IDs
NIAID #08-0053
Status last verified
Aug 2009
First submitted
22 Aug 2009
Last updated
10 Aug 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ciprofloxacin and Valortim in people with Anthrax, run by PharmAthene, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of changes from baseline for clinical laboratory tests and urinalysis, blood pressure, heart rate, respiratory rate, body temperature, physical examination and ECG (time frame: 134 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00964561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.

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