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

Phase 1

Suspended

• Conditions: Healthy
• Interventions: Drug: AZD5099; Drug: Placebo

• Registration Number: NCT01340183
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Study Start: 2011-05
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-30
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD5099	AZD5099	IV Dose
Placebo	Placebo	IV Dose

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of AZD5099	Ongoing throughout the study from consent (up to 28 days prior to dosing) through withdrawal or completion (up to 10 days after discharge).	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

Name	Time	Method
Blood samples to characterize the pharmacokinetics of AZD5099, 48 hour	48 hour post start of infusion	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	72 hour post start of infusion	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	10 hour post start of infusion	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	12 hour post start of infusion	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	24 hour post start of infusion	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	36 hour post start of infusion	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, pre-dose	Pre-dose	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	15 minutes post start of infusion	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	30 minutes post start of infusion	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	1 hour post start of infusion	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	2 hour post start of infusion	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	2.5 hour post start of infusion	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	3 hour post start of infusion	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	4 hour post start of infusion	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	5 hour post start of infusion	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	6 hour post start of infusion	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	8 hour post start of infusion	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	96 hour post start of infusion	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	120 hour post start of infusion	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	Between -12 to 0 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 \[fe(0-t)\].
Urine samples to characterize the pharmacokinetics of AZD5099, 0-4 hours	Between 0 - 4 hours post start of infusion	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	Between 4 - 8 hours post start of infusion	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	Between 8 - 12 hours post start of infusion	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	Between 12 - 24 hours post start of infusion	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	Between 24 - 48 hours post start of infusion	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	Between 48 - 72 hours post start of infusion	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	Between 72 - 96 hours post start of infusion	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	Between 96 - 120 hours post start of infusion	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 \[fe(0-t)\].

Trial Locations

Locations (1)

Research Site; 🇺🇸 Glendale, California, United States