Cancer
Conditions
Interventions
The volunteer will once receive 200 milligram (mg) of 14C-labeled JDQ443 as a
small drink of 20 milliliters (mL). This amount contains 3.7 MBq (100 µCi)
radioactivity. After administration of the st
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, aged 18 to 60 years, inclusive, at screening. 3. In good health as determined by no clinically significant findings from medical history, physical examination, vital signs, ECG, 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: - Body temperature from 35.0 °C to 37.5 °C, inclusive. - Systolic blood pressure (BP) from 90 to 139 mmHg, inclusive. - Diastolic BP from 45 to 89 mmHg, inclusive. - Pulse rate from 45 to 90 beats per minute, inclusive. 5. Participants must weigh at least 50 kg and no more than 120 kg to participate in the study and must have a body mass index (BMI) within the range of 18.0 to 29.9 kg/m² at screening. BMI = body weight (kg) / height2 (m2). 6. Participants agree to be available for the entire duration of the study and to be able to adhere to the study restrictions and visit schedule. 7. Participants must be able to communicate well with the Investigator and to comply with the requirements of the entire study.
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. The Investigator is expected to apply the appropriate due diligence (considering available information in public, IBs, and/or patient information) to ensure that the washout times detailed above are sufficient to avoid a carry-over of PK or PD or have an impact on participant safety by the other investigational drug. 2. Evidence of any remaining PD effects not having yet returned to baseline after previous exposure to an investigational drug (in the judgment of the Investigator). 3. Contraindications or hypersensitivity to the investigational compound/compound class or excipients being used in this study. 4. 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. 5. Recent history (500 ng/mL at screening or baseline. Further criteria apply, see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To determine the rates and routes of excretion of total radioactivity following a single 200 mg oral dose of [14C]JDQ443 in healthy male participants. - To determine the PK of total radioactivity in whole blood and plasma following a single 200 mg oral dose of [14C]JDQ443 in healthy male participants. - To characterize the PK of JDQ443 and known key metabolites, if applicable, in plasma and urine following a single 200 mg oral dose of [14C]JDQ443 in healthy male participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the safety and tolerability of a single 200 mg oral dose of [14C]JDQ443 in healthy male participants. | — |
Countries
Netherlands
Outcome results
None listed