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

AstraZeneca

Status and phase

Suspended

Phase 1

Conditions

Healthy

Treatments

Drug: AZD5099

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01340183

D0910C00015

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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