Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01015014
First received: October 20, 2009
Last updated: February 21, 2011
Last verified: November 2009
  Purpose

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.


Condition Intervention Phase
Gram-negative Bacterial Infection
Drug: AN3365
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: First-in-human, Two-stage, Randomized, Placebo-controlled, Double-blind, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of AN3365 in Single and Multiple Doses in Young Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate) [ Time Frame: Multiple time points up to 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality [ Time Frame: Multiple time points up to 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AN3365 Drug: AN3365
LP, 600 mg vial; reconstituted in Normal Saline
Placebo Comparator: Saline Drug: Placebo
0.9% sodium chloride for injection

Detailed Description:

Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Young healthy males, 18-45 years (inclusive) of age
  • Healthy as judged by a responsible physician with no clinically significant abnormality
  • Surgically sterile OR agrees to abstain from sexual intercourse with a female partner OR agrees to use a condom and spermicide during sexual intercourse with a female partner who uses another form of contraception
  • Body weight above 50 kg (Body Mass Index between 19 and 30 kg/m2)
  • Non-smokers
  • Willing and able to comply with study instructions and commit to all follow-up visits
  • Ability to understand, agree to and sign the study Informed Consent Form (ICF)

Exclusion Criteria:

  • History of serious adverse reactions or hypersensitivity to any drug; or who have a known allergy to any of the test product(s) or any components in the test product(s); or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
  • Any clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions
  • Abnormal physical findings of clinical significance at the screening examination or baseline
  • History of orthostatic hypotension
  • Clinically significant abnormal laboratory values
  • Presence or history of allergies requiring acute or chronic treatment
  • 12 lead ECG abnormalities
  • Major surgical interventions within 6 months of the study
  • Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result
  • Use of prescription or non-prescription drugs
  • Has a history of regular alcohol consumption
  • Loss of 500 mL blood or more during the 3 month period before the study
  • People that follow vegetarian or vegan diet
  • Symptoms of a significant somatic or mental illness in the four week period preceding drug administration
  • History of drug abuse or dependence within 12 months of the study
  • The subject has a positive pre-study alcohol or urine drug screen
  • Concurrent participation in another drug or device research study or within 60 days of post participation in another drug or device study
  • Considered by the Investigator to be unsuitable candidate for this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015014

Locations
Australia
CMAX
Adelaide, Australia
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lee Zane, MD, MAS, Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01015014     History of Changes
Other Study ID Numbers: AN3365-PK-101
Study First Received: October 20, 2009
Last Updated: February 21, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by Anacor Pharmaceuticals, Inc.:
Gram negative
bacteria
infection

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Gram-Negative Bacterial Infections
Infection

ClinicalTrials.gov processed this record on October 20, 2014