advanced solid tumors solid tumors
Conditions
Interventions
IMP and formulations: 14C-ASTX029 solution, 14C-ASTX029 IV formulation and
ASTX029 tablet
Route of Administration: Oral (tablet and solution) and intravenously (IV)
(solution) administration
Sponsors
Astex Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male subjects and female subjects of non-childbearing potential , aged 18 years to 65 years, inclusive, at Screening. 2. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and at Screening. 3. Women of non-childbearing potential should be surgically sterilized or physiologically incapable of becoming pregnant or should be postmenopausal. Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure. Postmenopausal women must have had >=12 months of spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) >=33.4 mIU/mL). All women must have a negative pregnancy test result at Screening and on Day -1 of Period 1. 4. Male subjects, if not surgically sterilized, 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 male subjects who are sexually active with women of childbearing potential (WOCBP) entails the use of a latex or other synthetic condom during any sexual activity with WOCBP until 90 days after the follow-up visit. Total abstinence, in accordance with the lifestyle of the subject, is also acceptable. 5. Satisfactory physical and mental health at Screening and on Day -1 on the basis of medical history, physical examination, clinical laboratory, 12-lead electrocardiogram (ECG) in triplicate, and vital signs, as judged by the Principal Investigator.
Exclusion criteria
Exclusion criteria: 1. Employee of clinical research organization (CRO) or the Sponsor. 2. Clinically significant systemic allergic disease or a history of significant drug and/or food allergies, including, but not limited to, a history of anaphylactic reactions, or allergic reactions due to any drug and/or food leading to significant morbidity. 3. Use of any prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to each admission to the clinic. 4. Use of any non-prescription drugs (excluding paracetamol), vitamin preparations and other food supplements, or herbal medications (eg, St John*s Wort) within 14 days prior to each admission to the clinic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • The amount of radioactivity excreted in urine and feces with an objective to recover >=90% of the radiolabeled ASTX026. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Concentration-time profile and PK parameters of total radioactivity from analysis of plasma, urine, and feces collected at identified timepoints. • PK parameter estimates for ASTX026 in plasma. • [14C]-metabolic profile and identified metabolites in plasma blood. • Major radioactive peak/metabolites in the urine and fecal radiochromatograms as a percentage of the radioactive dose. • Incidence and severity of treatment emergent adverse events (TEAEs). | — |
Countries
Netherlands
Outcome results
None listed