Cancer Cancer
Conditions
Interventions
The volunteer will be given 50 milligram of 14C labeled TNO155 as a capsule
with 240 milliliters of (tap) water. This amount contains 0.7 MBq (18.9 µCi)
radioactivity.
Sponsors
Novartis Pharma AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Healthy males age 18 to 55 years, inclusive, at screening. 3. In good health as determined by no clinically significant findings from medical history, physical examination, vital signs, ECG, echocardiogram, and laboratory tests, at screening. 4. At screening and at baseline (Day -1), vital signs after 5 minutes in supine position must be within the following ranges (inclusive): • Body temperature between 35.0 and 37.5°C°. • Systolic blood pressure (BP) between 90 and 139 mmHg. • Diastolic BP between 45 and 89 mmHg. • Pulse rate between 45 and 90 bpm. 5. Weight at least 50 kg with a body mass index (BMI) within the range of 18.0 to 29.9 kg/m2, inclusive. Further criteria apply.
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs within 6 months prior to admission (in case of therapeutics with expected long half-lives such as immunoglobin G antibodies) or use of other investigational drugs within 30 days prior to dosing (for small-molecule drugs with daily dosing scheme), or longer if required by local regulations. 2. Contraindication or hypersensitivity to the investigational compound/compound class or excipients being used in this study. 3. History or presence of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 4. Recent history (<3 months) of nicotine product use or a urine cotinine level >500 ng/mL, at screening or baseline. 5. Use of any prescription drugs (including moderate and strong CYP3A and UGT1A3 inhibitors or inducers), over-the-counter (OTC) medications, herbal supplements, or prescribed medicinal use of cannabis/marijuana/cannabidiol-containing products, or administration of any vaccine within the last 4 weeks prior to dosing. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group 1: • Excretion/mass balance of [14C]-radioactivity recovered in urine, feces, vomitus (if applicable), and expired air as percentage (%) of both the administered dose and the recovered dose. • Cmax, Tmax, AUClast, AUCinf, T1/2 and any other PK parameters as appropriate from the concentration-time data of 14C-radioactivity in whole blood and plasma. • Cmax, Tmax, AUClast, AUCinf, T1/2, Vz/F (TNO155 only), CL/F, (TNO155 only), Ae, CLr and any other PK parameter as appropriate from concentration vs. time data of TNO155 and the metabolite NIH741 in plasma and urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Group 1 and 2: •Frequency and severity of AEs including changes in laboratory values, vital signs and ECG intervals. | — |
Countries
Netherlands
Outcome results
None listed