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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01340183
Other study ID # D0910C00015
Secondary ID
Status Suspended
Phase Phase 1
First received April 20, 2011
Last updated November 30, 2011
Start date May 2011
Est. completion date December 2011

Study information

Verified date November 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Suspended
Enrollment 80
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
AZD5099
IV Dose
Placebo
IV Dose

Locations

Country Name City State
United States Research Site Glendale California

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the safety and tolerability of AZD5099 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. Ongoing throughout the study from consent (up to 28 days prior to dosing) through withdrawal or completion (up to 10 days after discharge). Yes
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, pre-dose Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. Pre-dose No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 15 min Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 15 minutes post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 30 min Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 30 minutes post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 1 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 1 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 2 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 2 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 2.5 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 2.5 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 3 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 3 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 4 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 4 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 5 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 5 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 6 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 6 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 8 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 8 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 10 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 10 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 12 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 12 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 24 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 24 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 36 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 36 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 48 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 48 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 72 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 72 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 96 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 96 hour post start of infusion No
Secondary Blood samples to characterize the pharmacokinetics of AZD5099, 120 hour Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, ?z, AUC, AUC(0-t), t½?z, Vz, Vdss, and CL. 120 hour post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, pre-dose 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)]. Between -12 to 0 hours No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 0-4 hours 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)]. Between 0 - 4 hours post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 4-8 hours 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)]. Between 4 - 8 hours post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 8-12 hours 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)]. Between 8 - 12 hours post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 12-24 hours 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)]. Between 12 - 24 hours post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 24-48 hours 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)]. Between 24 - 48 hours post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 48-72 hours 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)]. Between 48 - 72 hours post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 72-96 hours 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)]. Between 72 - 96 hours post start of infusion No
Secondary Urine samples to characterize the pharmacokinetics of AZD5099, 96-120 hours 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)]. Between 96 - 120 hours post start of infusion No
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