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

Last updated on March 6, 2019

FOR MORE INFORMATION
Study Location
CMAX
Adelaide, , Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gram-negative Bacterial Infection
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT01015014
Pfizer
Completed
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections

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