A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of HDM201 (Siremadlin) after a single oral dose of 25 mg [14C]HDM201 in healthy subjects
- Conditions
- Cancer10027656
- Registration Number
- NL-OMON49451
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Healthy males and/or females age 18 to 54 years included
Weighy at least 55 kg and no more than 120 kg
BMI 18.0 - 30 kg/m2
Females of childbearing potential (WOCBP).
Exposure to radiation at a level of 0.1 to1.0 mSv over the past year, 1.1 to
2.0 mSv over the past 2 years, or 2.1 to 3.0 mSv over the past 3 years, etc.,
e.g., due to systemic administration of radioactive substances, or to external
irradiation (e.g., by x-rays) for diagnostic,
therapeutic, job-related, or research purposes.
Use of other investigational drugs within 5 half-lives, or within 6 months (in
case of therapeutics with expected long half-lives such as immunoglobulin G
antibodies), or within 30 days prior to dosing (for
small molecule drugs with daily dosing scheme), or longer if required
by local regulations.
Any surgical or medical condition which might significantly alter the ADME of
drugs, or which may jeopardize the subject in case of participation in the
study.
Has absence of regular defecation pattern (subjects with a mean defecation
frequency of less than once per 2 days or chronic diarrhea).
Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV),
and/or human immunodeficiency virus (HIV).
Smokers (use of tobacco/nicotine products in the previous 3 months).
History or presence of clinically significant ECG abnormalities or a family
history or presence of prolonged QT-interval syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the routes and rates of excretion of [14C]HDM201 related<br /><br>radioactivity, including mass balance of total drug-related radioactivity in<br /><br>urine,<br /><br>feces, and excretion of radioactivity via expired air, following the<br /><br>administration of a single 25 mg oral dose of [14C]HDM201 in healthy subjects.<br /><br><br /><br>To determine the PK of total radioactivity in blood and plasma.<br /><br><br /><br>To characterize the single dose plasma PK of HDM201 and/or known key<br /><br>metabolite(s) if applicable.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of a single 25 mg oral dose of<br /><br>[14C]HDM201 administered in healthy male and/or female subjects.</p><br>