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

NCT01340183 | Suspended Phase 1

• 1 other identifier: D0910C00015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 (28)

• Blood samples to characterize the pharmacokinetics of AZD5099, pre-dose

  Pre-dose

• Blood samples to characterize the pharmacokinetics of AZD5099, 15 min

  15 minutes post start of infusion

• Blood samples to characterize the pharmacokinetics of AZD5099, 30 min

  30 minutes post start of infusion

• Blood samples to characterize the pharmacokinetics of AZD5099, 1 hour

  1 hour post start of infusion

• Blood samples to characterize the pharmacokinetics of AZD5099, 2 hour

  2 hour post start of infusion

Study Arms (2)

AZD5099

EXPERIMENTAL

IV Dose

Drug: AZD5099

Placebo

PLACEBO COMPARATOR

IV Dose

Drug: Placebo

Interventions

AZD5099 DRUG

IV Dose

AZD5099

Placebo DRUG

IV Dose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, United States

Location

MeSH Terms

Interventions

2-(4-((3,4-dichloro-5-methyl-1H-pyrrole-2-carbonyl)amino)-3-methoxy-1-piperidyl)-4-((2-methoxy-1-methylethyl)carbamoyl)thiazole-5-carboxylic acid

Study Officials

• Mark Yen, MD

  Parexel

  PRINCIPAL INVESTIGATOR

• David Melnick

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 1, 2011

Record last verified: 2011-11

Locations

US (1)