Single center, open-label study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO6889450 in healthy male volunteers
- Conditions
- 10039628Schizophrenia
- Registration Number
- NL-OMON51079
- Lead Sponsor
- F. Hoffman-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1. Able and willing to provide written informed consent and to comply with the
study protocol according to International Council for Harmonisation (ICH) and
local regulations.
2. Healthy participants aged 18 to 55 years of age, inclusive, at the time of
signing the ICF.
3. Male participants who are overtly healthy (defined by absence of evidence of
any active or chronic disease) as determined by medical evaluation including:
• A detailed medical and surgical history
• A complete physical examination
• Vital signs
• 12-lead ECG
• Hematology
• Blood chemistry
• Serology and urinalysis
4. Fluent in the language of the Investigator and study staff (Dutch or
English), and able to communicate with the study staff.
5. Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive at screening.
6. Male participants
During the treatment period and for at least 90 days after the final dose of
RO6889450 agreement to:
• Remain abstinent (refrain from heterosexual intercourse) or use contraceptive
measures such as a condom plus an additional contraceptive method that together
result in a failure rate of <1% per year, with a female partner who is not
pregnant and of childbearing potential (WOCBP, as defined in Section 1 of
Appendix 5).
• Refrain from donating sperm.
1. Any condition or disease detected during the medical interview/physical
examination that would render the participant unsuitable for the study, place
the participant at undue risk or interfere with the ability of the participant
to complete the study, as determined by the Investigator.
2. Disorders of the central nervous system (CNS), psychiatric disorders,
behavioral disturbances (e.g., cerebrovascular events, earlier, or current
major depression, post-traumatic stress disorder, anxiety, bipolar disorder,
severe migraine, Parkinson*s disease, attention deficit hyperactivity disorder).
3. Any personal or familial history (1st degree) of seizures, epilepsy, or
other convulsive condition; or previous significant head trauma, or other
factors predisposing to seizures.
4. History or evidence of any medical condition potentially altering the
absorption, metabolism, or elimination of drugs.
5. History of any clinically significant gastrointestinal, renal, hepatic,
bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological,
hematological or allergic disease, metabolic disorder, hypofertility, cancer,
or cirrhosis.
6. Sensitivity to any of the study treatments, or components thereof, or drug
or other allergy that, in the opinion of the Investigator, contraindicates the
participation in the study. Any major illness within one month before the
screening examination or any febrile illness within one week prior to screening
and up to first study drug administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* To characterize mass balance, routes, and rates of elimination of a single<br /><br>oral dose of 150 mg [14C]-labeled RO6889450<br /><br>* To assess the PK of total drug-related material, RO6889450, and its<br /><br>metabolite(s) as appropriate</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To assess the safety and tolerability of single dose administration of<br /><br>RO6889450<br /><br>* To identify and quantify the metabolic profiles of RO6889450 in plasma, feces<br /><br>and urine, and characterize any major metabolite(s)</p><br>