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

April 20, 2011
November 30, 2011
May 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01340183 on ClinicalTrials.gov Archive Site
  • 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)].
  • 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)].
Not Provided
Not Provided
 
Clinical Study Assessing the Safety, Tolerability, and Pharmacokinetics of Intravenous AZD5099 in Healthy Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD5099
    IV Dose
  • Drug: Placebo
    IV Dose
  • Experimental: AZD5099
    IV Dose
    Intervention: Drug: AZD5099
  • Placebo Comparator: Placebo
    IV Dose
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
80
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01340183
D0910C00015
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Mark Yen, MD Parexel
Study Director: David Melnick AstraZeneca
AstraZeneca
November 2011

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