Cancer
Conditions
Interventions
The volunteer will once receive 25 milligram (mg) of 14C-labeled HDM201 as an
oral capsule with 240 milliliters (mL) of (tap) water. This amount contains 3.7
MBq (100 µCi) radioactivity.
Sponsors
Novartis Pharma AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the routes and rates of excretion of [14C]HDM201 related radioactivity, including mass balance of total drug-related radioactivity in urine, feces, and excretion of radioactivity via expired air, following the administration of a single 25 mg oral dose of [14C]HDM201 in healthy subjects. To determine the PK of total radioactivity in blood and plasma. To characterize the single dose plasma PK of HDM201 and/or known key metabolite(s) if applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a single 25 mg oral dose of [14C]HDM201 administered in healthy male and/or female subjects. | — |
Countries
Netherlands
Outcome results
None listed