Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
NCT01015014
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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)
- 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
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Descriptive Information | |||||
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Brief Title ICMJE | Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||
Condition ICMJE | Gram-negative Bacterial Infection | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 64 | ||||
Original Estimated Enrollment ICMJE | 88 | ||||
Actual Study Completion Date ICMJE | May 13, 2010 | ||||
Actual Primary Completion Date | May 13, 2010 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01015014 | ||||
Other Study ID Numbers ICMJE | AN3365-PK-101 C3501001 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | March 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |