A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of [14C]JDQ443 following a single oral dose of JDQ443 in healthy male participants.
- Conditions
- Cancer10027656
- Registration Number
- NL-OMON51491
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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.
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 (<3 months prior to screening) of nicotine product use or a
urine cotinine level >500 ng/mL at screening or baseline.
Further criteria apply, see protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To determine the rates and routes of excretion of total radioactivity<br /><br>following a single 200 mg oral dose of [14C]JDQ443 in healthy male participants.<br /><br><br /><br>- To determine the PK of total radioactivity in whole blood and plasma<br /><br>following a single 200 mg oral dose of [14C]JDQ443 in healthy male participants.<br /><br><br /><br>- To characterize the PK of JDQ443 and known key metabolites, if applicable, in<br /><br>plasma and urine following a single 200 mg oral dose of [14C]JDQ443 in healthy<br /><br>male participants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the safety and tolerability of a single 200 mg oral dose of<br /><br>[14C]JDQ443 in healthy male participants.</p><br>