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Clinical Study Assessing the Safety, Tolerability, and Pharmacokinetics of Intravenous AZD5099 in Healthy Subjects

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01340183
First received: April 20, 2011
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of the drug AZD5099 after intravenous administration of single doses in healthy volunteers. The results from this study will form the basis for decisions regarding the future development of AZD5099 as a novel antibiotic for the treatment of serious infections in humans.


Condition Intervention Phase
Healthy
 Drug: AZD5099
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics in Intravenous AZD5099 After Single Ascending Doses in Healthy Male and Female Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the safety and tolerability of AZD5099 [ Time Frame: Ongoing throughout the study from consent (up to 28 days prior to dosing) through withdrawal or completion (up to 10 days after discharge). ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of AZD5099 by documenting: 1) the incidence and severity of adverse events, 2) abnormalities and time matched comparison from Day -1 to Day 1 of core body temperature and vital sign assessments, 3) electrocardiograms (ECGs), 4) telemetry, 5) clinical laboratory assessments, 6) physical examinations, and 7) withdrawals.


Secondary Outcome Measures:
  • Blood samples to characterize the pharmacokinetics of AZD5099, pre-dose [ Time Frame: Pre-dose ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 15 min [ Time Frame: 15 minutes post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 30 min [ Time Frame: 30 minutes post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 1 hour [ Time Frame: 1 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 2 hour [ Time Frame: 2 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 2.5 hour [ Time Frame: 2.5 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 3 hour [ Time Frame: 3 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 4 hour [ Time Frame: 4 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 5 hour [ Time Frame: 5 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 6 hour [ Time Frame: 6 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 8 hour [ Time Frame: 8 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 10 hour [ Time Frame: 10 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 12 hour [ Time Frame: 12 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 24 hour [ Time Frame: 24 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 36 hour [ Time Frame: 36 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 48 hour [ Time Frame: 48 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 72 hour [ Time Frame: 72 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 96 hour [ Time Frame: 96 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Blood samples to characterize the pharmacokinetics of AZD5099, 120 hour [ Time Frame: 120 hour post start of infusion ] [ Designated as safety issue: No ]
    Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.

  • Urine samples to characterize the pharmacokinetics of AZD5099, pre-dose [ Time Frame: Between -12 to 0 hours ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 0-4 hours [ Time Frame: Between 0 - 4 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 4-8 hours [ Time Frame: Between 4 - 8 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 8-12 hours [ Time Frame: Between 8 - 12 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 12-24 hours [ Time Frame: Between 12 - 24 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 24-48 hours [ Time Frame: Between 24 - 48 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 48-72 hours [ Time Frame: Between 48 - 72 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 72-96 hours [ Time Frame: Between 72 - 96 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].

  • Urine samples to characterize the pharmacokinetics of AZD5099, 96-120 hours [ Time Frame: Between 96 - 120 hours post start of infusion ] [ Designated as safety issue: No ]
    Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].


Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD5099
IV Dose
 Drug: AZD5099
IV Dose
Placebo Comparator: Placebo
IV Dose
 Drug: Placebo
IV Dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling
  • Healthy male and female (with nonchildbearing potential) volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
  • Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
  • Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels within the laboratory-defined post-menopausal range
  • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
  • Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until at least 3 months after dosing with the investigational product
  • Have a body mass index (BMI) between 18 and 30.5 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive

Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
  • History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms >3 times a week, or blood in stool in previous 6 months not related to anal trauma
  • For male volunteers any history of sexual dysfunction or impotence as judged by the Investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340183

Locations
United States, California
Research Site
Glendale, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Mark Yen, MD Parexel
Study Director: David Melnick AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01340183     History of Changes
Other Study ID Numbers: D0910C00015
Study First Received: April 20, 2011
Last Updated: November 30, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by AstraZeneca:
Phase I
safety
tolerability
pharmacokinetics
AZD5099
 volunteers
safety of the drug AZD5099
blood and urine levels of AZD5099
single intravenous doses
healthy volunteers

ClinicalTrials.gov processed this record on May 21, 2013