A PHASE 1 TRIAL TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, AND PHARMACOKINETICS OF 14C-E7727 IN HEALTHY VOLUNTEERS >=65 YEARS OF AGE
- Conditions
- Myelodysplastisch syndroomMDSMyelodysplastic syndromes
- Registration Number
- NL-OMON48473
- Lead Sponsor
- Astex Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
1. Gender: male or female; females must be postmenopausal
2. Age: >=65 years, at screening.
3. Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive.
4. Status: healthy subjects
5. Male subjects, if not surgically sterilized, with a female partner of childbearing potential must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the subject, is also acceptable.
6. All prescribed medication must have been stopped at least 30 days prior to each admission to the clinical research center.
7. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John*s Wort) must have been stopped at least 14 days prior to each admission to the clinical research center. An exception is made for paracetamol, which is allowed up to each admission to the clinical research center.
8. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, soft drinks, chocolate, energy drinks), and grapefruit (juice) and tobacco products from 48 hours prior to each admission to the clinical research center.
9. Satisfactory physical and mental health on the basis of medical history, physical examination, clinical laboratory, 12-lead electrocardiogram (ECG), and vital signs, as judged by the PI.
10. Willing and able to sign the ICF.
11. Subject is able to understand and comply with the study procedures and understands the risks involved in the study
1. Employee of PRA or the Sponsor.
2. History of relevant drug and/or food allergies.
3. Using tobacco products and/or alcohol in the 48 hours (2 days) prior to first admission to the clinical research center is not allowed.
4. Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the subject to high risk of noncompliance with the protocol.
5. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol ) at screening and each admission to the clinical research center.
6. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
7. Positive screen for hepatitis B surface antigen (HBsAg), antihepatitis C virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV) 1 and 2 antibodies.
8. Participation in an investigational drug study within 60 days prior to the first drug administration in the current study. Participation in more than 4 other drug studies in the year prior to the first drug administration in the current study.
9. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liter of blood (for female subjects) in the 10 months prior to the first drug administration in the current study.
10. Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the Investigator.
11. Unsuitable peripheral veins for infusion or blood sampling.
12. Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year prior to screening.
13. Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical study in the period of 1 year prior to screening.
14. Irregular defecation pattern (less than once per 2 days).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To identify and quantify the main excretion pathways of E7727.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the F of E7727 after single dose administration in the fasted<br /><br>condition.<br /><br>To determine the Fa of E7727.<br /><br>To determine the PK of E7727 following oral and IV administration.<br /><br>To determine the safety and tolerability of E7727 following oral and IV<br /><br>administration.<br /><br>To identify the metabolites of E7727 in plasma, urine, and feces, if possible.</p><br>