A Non-Randomized, Open Label, Adaptive, Single Center, Positron Emission Tomography (PET) Study to Assess Distribution of RO7248824 in the Central Nervous System Following Single Intrathecal Doses of [89Zr]-Labeled RO7248824 in Healthy Male Participants

Completed

Conditions: Angelman syndrome
10029305

Registration Number: NL-OMON52457

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

1. Able and willing to provide written informed consent and to comply with the
study protocol according to ICH and local regulations
2. Aged 25 to 55 years at the time of dosing
3. 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 and neurological examination
- Vital signs
- 12-lead ECG
- Hematology
- Coagulation
- Blood chemistry
- Serology and urinalysis
4. Fluent in the language of the Investigator and study staff, and able to
communicate with the study staff
5. Body mass index of 18 to 30 kg/m2 at screening
6. Male participants only who, for 3 months after the dosing of RO7248824,
agree to:
- Remain abstinent or use contraceptive barrier measures such as a condom, with
a female partner of childbearing potential, or pregnant female partner, to
avoid exposing the embryo
- Refrain from donating sperm
The reliability of sexual abstinence for male enrollment eligibility needs to
be evaluated in relation to the duration of the clinical study and the
preferred and usual lifestyle of the participant. Periodic abstinence (e.g.,
calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal
are not acceptable methods of preventing drug exposure.

Exclusion Criteria

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. History or presence of cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable
of significantly altering the absorption, metabolism, or elimination of drugs;
constituting a risk when taking the study treatment; or interfering with the
interpretation of data
3. History or presence of clinically significant cardiovascular disease in the
opinion of the Investigator, including, but not limited to: left ventricular
ejection fraction < 40%, (assessed by echocardiogram/multiple-gated acquisition
scan [ECHO/MUGA]) congestive heart failure Class IV New York Heart Association
(NYHA), left ventricular outflow obstruction (aortic stenosis, idiopathic
hypertrophic subaortic stenosis), symptomatic coronary artery disease, prior
myocardial infarction,
congestive heart failure requiring hospitalization, prior cerebrovascular
accident
4. History or presence of an abnormal ECG that is clinically significant in the
Investigator's opinion (e.g., PQ/PR interval > 220 ms, QTcF > 450 ms)
5. Uncontrolled arrhythmias or history of clinically significant arrhythmias
including: ventricular arrhythmias or risk factors for ventricular arrhythmias
(such as clinically significant electrolyte abnormalities (e.g., hypokalemia,
hypomagnesemia, hypocalcemia); second- or third-degree atrioventricular block;
family history of sudden unexplained death or long QT syndrome; congenital
hypertrophic or dilated cardiomyopathy