A single-center, open-label study to evaluate the absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics of ganaplacide (KAF156) following a single oral dose of 400 mg [14C]ganaplacide in healthy male participants.
- Conditions
- an infectious disease caused by parasites that are transmitted through a mosquito biteMalaria10014142
- Registration Number
- NL-OMON51536
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
1. Signed informed consent must be obtained prior to participation in the study.
2. Healthy males, aged 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, electrocardiogram (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 (unless deemed not clinically
significant by the investigator; the clinical considerations must be
documented):
• 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 40 to 90 beats per minute, inclusive.
5. Participants must weigh at least 50 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 another investigational drug within the following time intervals
before dosing:
• For investigational drugs with long half-life (e.g., antibodies): use of
another investigational agent at screening, or 6 months prior to dosing, or
within a period corresponding to less than 5 half-lives of the agent before
dosing, whichever is longer; or longer if required by local regulations.
• For investigational drugs with short half-life (e.g., small molecules): use
of another investigational drug at screening, or 30 days prior to dosing, or
within a period corresponding to less than 5 half-lives of the drug before
dosing, whichever is longer; 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 pharmacodynamics (PD) or have an impact on participant
safety by the other investigational drug.
2. History of hypersensitivity to the investigational compound/compound class
or excipients being used in this study.
3. History or presence of malignancy of any organ system, treated or untreated,
within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases.
4. Recent history (<3 months prior to screening) 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
inhibitors or inducers), over-the-counter (OTC) medications, herbal
supplements, or cannabis/marijuana/cannabidiol-containing products, within 4
weeks prior to dosing. Note: If needed (i.e. an incidental and limited need up
to 2 g per day), acetaminophen is acceptable, but must be documented in the
concomitant medications page of the eCRF.
6. Use of any dietary supplements (vitamins included) within 2 weeks prior to
dosing.
7. Significant illness which has not resolved within 2 weeks prior to dosing.
Further criteria apply, see protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• To determine the routes and rates of excretion of [14C]ganaplacide related<br /><br>radioactivity, including mass balance of total drug-related radioactivity in<br /><br>urine, feces, and excretion of radioactivity via exhaled air, following a<br /><br>single oral dose of [14C]ganaplacide in healthy male participants.<br /><br>• To determine the PK of total radiolabeled components in blood and plasma<br /><br>following a single 400 mg oral dose of [14C]ganaplacide in healthy male<br /><br>participants.<br /><br>• To characterize the PK of ganaplacide and known key metabolites M31 (RHF218)<br /><br>and M37a (GOU089), if applicable, in plasma following a single 400 mg oral dose<br /><br>of [14C]ganaplacide in healthy male participants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To assess the safety and tolerability of a single 400 mg oral dose of<br /><br>[14C]ganaplacide in healthy male participants.</p><br>