Clinical study assessing the safety, tolerability, and pharmacokinetics of intravenous AZD5099 in healthy subjects

Study identifier:D0910C00015

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment on Hold

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

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5099, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 May 2011

Estimated Primary Completion Date: 01 Dec 2011

Estimated Study Completion Date: 01 Dec 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: AZD5099 IV Dose	Drug: AZD5099 IV Dose
Placebo Comparator: Placebo IV Dose	Drug: Placebo IV Dose

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1686&filename=CSR-D0910C00015.pdf
Download
CSR-D0910C00015.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

001-800-236-9933

[email protected]

Investigators

Principal Investigator

Mark Yen

PAREXEL