Clinical Study Assessing the Safety, Tolerability, and Ph... | NCT01340183

NCT01340183

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
AZD5099	Experimental	IV Dose	Drug: AZD5099
Placebo	Placebo Comparator	IV Dose	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD5099	Drug	IV Dose	AZD5099
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).

Secondary Outcomes

Measure	Description	Time Frame
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, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.	Pre-dose
Blood samples to characterize the pharmacokinetics of AZD5099, 15 min

Eligibility Module

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

Name	Affiliation	Role
Mark Yen, MD	Parexel	Principal Investigator
David Melnick	AstraZeneca	Study Director