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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects - NCT00928083-33025(Clinical Trial 299778)



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City:  Miramar
State:  
FL
Zip Code: 33025
Conditions: Malaria
Purpose: OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent. Part A will investigate the safety, tolerability and pharmacokinetics (PK) of single oral escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose proportionality. In Part B, the effect of food on a single oral dose of OZ439 will be investigated in a 2-way crossover design. Part C will investigate the safety, tolerability and PK profile of multiple oral doses of OZ439. The starting oral dose will be 50 mg and the maximum single dose to be administered will not exceed 1600 mg per subject. The maximum duration of dosing proposed is 3 days. The starting dose of 50 mg/kg is appropriate for OZ439 since this is not the first drug from this class and previously arteflene and arterolane were found to be safe and well tolerate in Phase I and Phase II studies. The toxicology studies to date show that a 50 mg dose of OZ439 is equivalent to 0.1 mg/kg dose which is 200 to 300 times lower than the NOEAL for dogs and rats in a 14 day toxicity study. OZ439 is a new drug proposed for further investigation in a Phase I clinical safety and PK study in healthy male and female subjects. The preclinical safety profile of oral administration of OZ439 supports first administration to humans using an initial dose of 50 mg.
Study summary:
Criteria: Inclusion Criteria: 1. Healthy male and female subjects between 18 and 55 years of age (inclusive). 2. Body mass Index (BMI) between 18 and 30 kg/m2, inclusive; and a total body weight >60 kg (132 lbs). 3. Healthy as determined by pre-study medical history, physical examination (including body temperature), 12 Lead ECG. 4. Females of childbearing potential must use 1 of the following acceptable birth control methods throughout the study and for 30 days after the last dose of study drug: 1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to the first dose of the study drug. 2. Intrauterine device (IUD) in place for at least 3 months prior to the first dose of study drug. 3. Barrier methods (condom or diaphragm) with spermicide starting at least 14 days prior to the first dose of study drug through 30 days after the last dose of study drug. 4. Surgical sterilization of the partner(s) (vasectomy with zero sperm count for 6 months minimum prior to the first dose of study drug). 5. Hormonal contraceptives starting at least 3 months prior to the first dose of study drug. In addition, subjects must agree to use a barrier method (condom or diaphragm) with spermicide at least 14 days prior to the first dose of study drug through 30 days after the last dose of study drug. 5. Post-menopausal women with amenorrhea for at least 1 year will be eligible confirmed by FSH. 6. Male subjects must agree to use a double barrier method of contraception, condom plus spermicide (and diaphragm plus spermicide in female partner) from the time of the first dose of study drug through 90 days after the last dose of study drug and must also agree to not donate sperm for 90 days after the last dose of study drug. Vasectomy with zero sperm count for 6 months minimum prior to the first dose of study drug is an acceptable form of contraception. 7. Clinical laboratory tests within the reference ranges. 8. Able and willing to give written informed consent. 9. Willing and able to adhere to the lifestyle guideline restrictions outlined in the protocol. 10. Willing and able to be confined to the Clinical Research Unit as required by the protocol. Exclusion Criteria: 1. Evidence of or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or current infection. 2. Evidence of or history of clinically significant gastrointestinal (excluding appendectomy and cholecystectomy) disease or current infection. 3. Any condition that could possibly affect drug absorption, e.g., gastrectomy. 4. History of post-antibiotic colitis. 5. Breast feeding. 6. QTc greater than 450 msec for males and 470 msec for females as corrected by the Bazett formula. 7. History of drug or alcohol abuse within the past 2 years prior to Screening. 8. Tobacco users (includes users who stopped smoking less than 90 days prior to the screening evaluation). [Note: "Tobacco use" includes smoking and the use of snuff and chewing tobacco, and other nicotine or nicotine containing products.] 9. Received an investigational drug or participated in another research study within 30 days of the first dose of study drug in any part of the study. 10. Use of prescription drugs within 14 days prior to the first dose of study drug in Period 1, or need for any antibiotic during the study. 11. Received any non prescription medications, vitamins, herbal supplements or dietary supplements within 7 days of administration of the first dose of study drug in Period 1, unless prior approval is granted by both the Investigator and Sponsor. Excluded from this list is intermittent use of acetaminophen at doses of less than 2 g/day. 12. Consumed alcohol within 72 hours of Day -1 in any part of the study, or have a positive alcohol screen at screening or each admission to the Clinical Research Unit (CRU). 13. Subject who consumed grapefruit juice or juices containing grapefruit or ate grapefruit within 7 days prior to the first dose of study drug in any part of the study. 14. Positive serum pregnancy test at the Screening Visit or on Day -1 prior to inclusion in any part of the study. 15. Positive test for human immunodeficiency virus (HIV-1), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV). 16. Positive urine drug screen at Screening or admission to the CRU. 17. History of intolerance or hypersensitivity to artemisinins. 18. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. 19. Subjects who have donated blood or experienced significant blood loss within 60 days of screening for the study. 20. Subjects whose hemoglobin is <12.5 g/dL for males and <11.5 g/dL for females. 21. There is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason the investigator considers the subject inappropriate for participation in the study.
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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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