A Phase 1 Study to Assess the Mass Balance, Absolute Bioavailability, and Pharmacokinetics of 14C-ASTX029 in Healthy Volunteers
- Conditions
- advanced solid tumorssolid tumors
- Registration Number
- NL-OMON51576
- Lead Sponsor
- Astex Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• The amount of radioactivity excreted in urine and feces with an objective to<br /><br>recover >=90% of the radiolabeled ASTX026.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Concentration-time profile and PK parameters of total radioactivity from<br /><br>analysis of plasma, urine, and feces collected at identified timepoints.<br /><br>• PK parameter estimates for ASTX026 in plasma.<br /><br>• [14C]-metabolic profile and identified metabolites in plasma blood.<br /><br>• Major radioactive peak/metabolites in the urine and fecal radiochromatograms<br /><br>as a percentage of the radioactive dose.<br /><br>• Incidence and severity of treatment emergent adverse events (TEAEs).</p><br>