Crossover Trial of the Effect of a High-Fat Meal on the PK of Oral CHR 2797 in Healthy Male Subjects
This trial is active, not recruiting.
|Start date||June 2012|
|End date||July 2012|
|Trial size||18 participants|
|Trial identifier||NCT01638442, TST101|
The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.
|Endpoint classification||safety study|
|Intervention model||crossover assignment|
|Primary purpose||basic science|
Safety Outcome Measurement
time frame: 10 days
time frame: 10 days
time frame: 10 days
Male participants from 18 years up to 55 years old.
- Male subjects between 18 and 55 years of age, inclusive.
- Within BMI range of 18.5 to 29.9 kg/m2, inclusive.
- In good health, determined by no clinically significant ongoing diseases or other conditions that require medication, and/or any other findings from medical history, physical examination, 12-lead ECG, and vital signs.
- Clinical laboratory evaluations (including chemistry panel fasted [fasted approximately 10 hours], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol; Appendix A).
- Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus [anti-HCV], and negative HIV antibody screens (Appendix A);
- Males will either be sterile or agree to use 1 of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives from Check-in (Day -1 of Period 1) until 90 days following Clinic Discharge (Day 10).
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).
- Have a disease or condition that requires daily medication.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed).
- History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
- History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1 of Period 1).
- Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1 of Period 1).
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in (Day -1 of Period 1).
- Use of any prescription medications/products within 14 days prior to Check-in (Day 1 of Period 1), unless deemed acceptable by the Investigator;
- Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
- Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
- Poor peripheral venous access.
- Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive.
- Receipt of blood products within 2 months prior to Check-in (Day -1 of Period 1).
- Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
|Official title||An Open-label, Randomized, Two-way Crossover Trial of the Effect of a High-Fat Meal on the Pharmacokinetics of Oral Tosedostat (CHR 2797) in Healthy Male Subjects|
|Principal investigator||Randall Stoltz, MD|
|Description||This will be a single center, open-label, 2-arm, 2-way, crossover trial to assess the effect of food on CHR-2797 PK following a single 120 mg dose. Approximately 18 normal, healthy male subjects will be enrolled with at least 12 subjects completing the study. Two 60 mg capsules will be administered for a 120 mg dose of CHR-2797 on Days 1 and 8 with a high-fat meal or in the fasted state according to the randomization schedule. Subjects will be confined at the clinical research unit (CRU) from the time of Period 1 Check-in until Clinic Discharge on Day 3, and will return to the CRU on Day 7 for Period 2 Check-in and remain in the CRU until Study Completion (on Day 10 of Period 2). Blood samples for PK analysis will be collected through 48 hours post dose.|
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