A Multiple Daily Oral Dose Study of DUR-928 in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Pharmacokinetics of DUR-928 in Healthy Volunteers Following Daily Oral Dosing
INC Research
28 participants
Mar 23, 2015
Interventional
Conditions
Summary
This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given to healthy volunteers, once daily for 5 days at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the 5 day dosing period, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream). This study will also look at the effect the food may have of the pharmacokinetics of DUR-928.
Eligibility
Inclusion Criteria5
- Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening;
- Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed;
- Female subjects must be of non-childbearing potential (i.e., surgically sterilized via hysterectomy, oophorectomy, or bilateral tubal ligation, physiologically incapable of becoming pregnant, including any female who is post-menopausal; post menopausal is defined as documented amenorrhea for at least 1 year with an FSH >/= 40 mIU/ml if menses has occurred within 2 years);
- Willing and be able to be admitted to the clinical study unit for 7 nights and 8 days;
- Able to abstain from alcohol and tobacco use during the trial.
Exclusion Criteria6
- Significant blood loss or donated blood in the 30 days prior to study participation
- Participation in an investigational drug study within 30 days prior to dosing.
- History of drug or alcohol abuse.
- Use of any medications, including OTC and herbal or nutritional supplements during the week prior to drug dosing
- Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test.
- Clinically significant abnormalities
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Interventions
DUR-928 powder for reconstitution. In Cohort 1 and Cohort 2, each subject will receive 5 daily doses of either active DUR-928 or placebo (calcium carbonate) according to the Cohort they are participating in and the intervention they are randomised to. In Cohort 3 each subject will receive a single dose of DUR-298 in an open-label (fasted/fed) crossover design. There will be a 3-7 day washout between fasted and fed periods. The doses of the intervention are described below per cohort: Cohort 1: DUR-928 or placebo (100 mg) Cohort 2: DUR-928 or placebo (300 mg) Cohort 3: DUR-928 (300mg), in fasted and fed state
Locations(1)
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ACTRN12615000267550