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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01340183
• Other study ID #: D0910C00015
• 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

• Healthy

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