Clinical trial NCT01340183: Clinical Study Assessing the Safety, Tolerability, and Pharmacokinetics of Intravenous AZD5099 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
safety
tolerability
pharmacokinetics
AZD5099
volunteers
safety of the drug AZD5099
blood and urine levels of AZD5099
single intravenous doses
healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: To assess the safety and tolerability of AZD5099
timeFrame: Ongoing throughout the study from consent (up to 28 days prior to dosing) through withdrawal or completion (up to 10 days after discharge).
Secondary outcomes:
measure: Blood samples to characterize the pharmacokinetics of AZD5099, pre-dose
timeFrame: Pre-dose
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 15 min
timeFrame: 15 minutes post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 30 min
timeFrame: 30 minutes post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 1 hour
timeFrame: 1 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 2 hour
timeFrame: 2 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 2.5 hour
timeFrame: 2.5 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 3 hour
timeFrame: 3 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 4 hour
timeFrame: 4 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 5 hour
timeFrame: 5 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 6 hour
timeFrame: 6 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 8 hour
timeFrame: 8 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 10 hour
timeFrame: 10 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 12 hour
timeFrame: 12 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 24 hour
timeFrame: 24 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 36 hour
timeFrame: 36 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 48 hour
timeFrame: 48 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 72 hour
timeFrame: 72 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 96 hour
timeFrame: 96 hour post start of infusion
measure: Blood samples to characterize the pharmacokinetics of AZD5099, 120 hour
timeFrame: 120 hour post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, pre-dose
timeFrame: Between -12 to 0 hours
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 0-4 hours
timeFrame: Between 0 - 4 hours post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 4-8 hours
timeFrame: Between 4 - 8 hours post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 8-12 hours
timeFrame: Between 8 - 12 hours post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 12-24 hours
timeFrame: Between 12 - 24 hours post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 24-48 hours
timeFrame: Between 24 - 48 hours post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 48-72 hours
timeFrame: Between 48 - 72 hours post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 72-96 hours
timeFrame: Between 72 - 96 hours post start of infusion
measure: Urine samples to characterize the pharmacokinetics of AZD5099, 96-120 hours
timeFrame: Between 96 - 120 hours post start of infusion
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
Study officials:
affiliation: Parexel
name: Mark Yen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: David Melnick
role: STUDY_DIRECTOR
References: