Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment

NCT04486625

Last updated date
Study Location
Prism Clinical Research, LLC
Saint Paul, Minnesota, 55114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy female subjects and/or male subjects between the ages of 18 and 75 years, inclusive. Male and female subjects of childbearing potential must agree to use highly effective method(s) of contraception

- Body mass index (BMI) of 17.5 to 40.5 kg/m2; and a total body weight >50 kg (110 lb)

- Stable renal function defined as

- Normal renal function (eGFR>/= 80 mL/min) at Screening based on the Day -2 value, using the MDRD formula adjusting for BSA

- Demographically comparable to the group of subjects with severe impaired renal function Specific Requirements for Subjects with Severe Renal Impairment

- Good general health commensurate with the population with chronic kidney disease.

- Documented severe renal impairment indicated by eGFR >15 -

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Positive urine drug test


- History of regular alcohol use (within 6 months) exceeding 7 drinks/week for female or
14 drinks/week for male subjects


- Treatment with an investigational product within 30 days or 5 half-lives preceding the
first dose of investigational product (whichever is longer)


- Subjects with abnormalities in clinical laboratory tests (AST, ALT, Total bilirubin,
aPTT, PT, INR) at Screening


- Pregnant females; breastfeeding females; fertile male subjects and female subjects of
childbearing potential who are unwilling or unable to use a highly effective method of
contraception


- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of investigational product.
For subjects with severe renal impairment, concomitant medications may be given if
considered necessary for the subject welfare (eg, standard therapy for underlying
diseases), are not contraindicated with the study drug, and are unlikely to interfere
with the PK/PD response of the study drug. Use of oral anticoagulants and potent
inhibitors of OAT1 and/or OAT3 (eg, probenecid) are prohibited in all subjects.


- Blood donation (excluding plasma donations) of approximately 1 pint or more within 60
days prior to dosing


- History of sensitivity to heparin or heparin-induced thrombocytopenia


- History of serious allergy, hypersensitivity or any serious reaction to aztreonam,
carbapenem, monobactam or other beta-lactam antibiotics, avibactam, or any of the
excipients of the respective (investigational) medicinal products


- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C


- Other acute or chronic medical or psychiatric condition


- Past or current history of epilepsy or seizure disorders excluding febrile seizures of
childhood Exclusion criteria: Subjects with Severe Renal Impairment


- Any significant hepatic, cardiac, or pulmonary disease


- Renal allograft recipients or subjects who are clinically nephrotic


- Subjects requiring dialysis


- Screening supine 12-lead ECG demonstrating QT interval corrected by Fridericia's
formula (QTcF) >470 msec or a QRS interval >120 msec


- Screening supine BP >/=180 millimeters of mercury (mm Hg) (systolic) or >/=110 mm Hg
(diastolic), on a single measurement (confirmed by a single repeat, if necessary)
following at least 5 minutes of rest Exclusion criteria: Subjects with Normal Renal
Function


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including clinically relevant and significant drug allergies, but
excluding untreated, asymptomatic, seasonal allergies at time of dosing)


- Screening supine 12-lead ECG demonstrating QTcF >450 msec or a QRS interval >120 msec


- Screening supine BP >/=140 mm Hg (systolic) or >/=90 mm Hg (diastolic), following at
least 5 minutes of supine rest

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Official Title  ICMJE AN OPEN-LABEL, PARALLEL-GROUP, PHARMACOKINETIC STUDY OF MULTIPLE INTRAVENOUS DOSES OF AZTREONAM AND AVIBACTAM IN SUBJECTS WITH SEVERE RENAL IMPAIRMENT AND NORMAL RENAL FUNCTION
Brief Summary This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed dosing adjustment in severe renal impairment which was based on modelling/simulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Renal Insufficiency
Intervention  ICMJE
  • Drug: Aztreonam-Avibactam
    500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours
  • Drug: Aztreonam-Avibactam
    675/225 mg ATM/AVI loading infusion, followed by 675/225 mg ATM/AVI extended loading infusion, then 675/225 mg ATM/AVI maintenance dose infusion every 8 hours
Study Arms  ICMJE
  • Experimental: Cohort 1
    Normal renal function
    Intervention: Drug: Aztreonam-Avibactam
  • Experimental: Cohort 2
    Severe renal impairment (not on dialysis)
    Intervention: Drug: Aztreonam-Avibactam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 14, 2021
Estimated Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female subjects and/or male subjects between the ages of 18 and 75 years, inclusive. Male and female subjects of childbearing potential must agree to use highly effective method(s) of contraception
  • Body mass index (BMI) of 17.5 to 40.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Stable renal function defined as </=25% difference between 2 measurements of eGFR obtained on 2 separate occasions during the screening period that are at least 72 hours but no more than 14 days apart Specific Requirements for Healthy Subjects with Normal Renal Function
  • Normal renal function (eGFR>/= 80 mL/min) at Screening based on the Day -2 value, using the MDRD formula adjusting for BSA
  • Demographically comparable to the group of subjects with severe impaired renal function Specific Requirements for Subjects with Severe Renal Impairment
  • Good general health commensurate with the population with chronic kidney disease.
  • Documented severe renal impairment indicated by eGFR >15 -</=30 mL/min but not requiring hemodialysis, using the MDRD formula adjusting for BSA

Exclusion Criteria:

  • Positive urine drug test
  • History of regular alcohol use (within 6 months) exceeding 7 drinks/week for female or 14 drinks/week for male subjects
  • Treatment with an investigational product within 30 days or 5 half-lives preceding the first dose of investigational product (whichever is longer)
  • Subjects with abnormalities in clinical laboratory tests (AST, ALT, Total bilirubin, aPTT, PT, INR) at Screening
  • Pregnant females; breastfeeding females; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. For subjects with severe renal impairment, concomitant medications may be given if considered necessary for the subject welfare (eg, standard therapy for underlying diseases), are not contraindicated with the study drug, and are unlikely to interfere with the PK/PD response of the study drug. Use of oral anticoagulants and potent inhibitors of OAT1 and/or OAT3 (eg, probenecid) are prohibited in all subjects.
  • Blood donation (excluding plasma donations) of approximately 1 pint or more within 60 days prior to dosing
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • History of serious allergy, hypersensitivity or any serious reaction to aztreonam, carbapenem, monobactam or other beta-lactam antibiotics, avibactam, or any of the excipients of the respective (investigational) medicinal products
  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Other acute or chronic medical or psychiatric condition
  • Past or current history of epilepsy or seizure disorders excluding febrile seizures of childhood Exclusion criteria: Subjects with Severe Renal Impairment
  • Any significant hepatic, cardiac, or pulmonary disease
  • Renal allograft recipients or subjects who are clinically nephrotic
  • Subjects requiring dialysis
  • Screening supine 12-lead ECG demonstrating QT interval corrected by Fridericia's formula (QTcF) >470 msec or a QRS interval >120 msec
  • Screening supine BP >/=180 millimeters of mercury (mm Hg) (systolic) or >/=110 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest Exclusion criteria: Subjects with Normal Renal Function
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically relevant and significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • Screening supine 12-lead ECG demonstrating QTcF >450 msec or a QRS interval >120 msec
  • Screening supine BP >/=140 mm Hg (systolic) or >/=90 mm Hg (diastolic), following at least 5 minutes of supine rest
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04486625
Other Study ID Numbers  ICMJE C3601006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP