A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of TNO155 following a single oral dose of [14C]TNO155 in healthy male participants
- Conditions
- Cancer
- Registration Number
- NL-OMON51295
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Group 1:<br /><br>• Excretion/mass balance of [14C]-radioactivity recovered in urine, feces,<br /><br>vomitus (if applicable), and expired air as percentage (%) of both the<br /><br>administered dose and the recovered dose.<br /><br>• Cmax, Tmax, AUClast, AUCinf, T1/2 and any other PK parameters as appropriate<br /><br>from the concentration-time data of 14C-radioactivity in whole blood and plasma.<br /><br>• Cmax, Tmax, AUClast, AUCinf, T1/2, Vz/F (TNO155 only), CL/F, (TNO155 only),<br /><br>Ae, CLr and any other PK parameter as appropriate from concentration vs. time<br /><br>data of TNO155 and the metabolite NIH741 in plasma and urine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Group 1 and 2:<br /><br>•Frequency and severity of AEs including changes in laboratory values, vital<br /><br>signs and ECG intervals.</p><br>