An open-label, mass balance study to investigate the absorption, distribution, metabolism and excretion of [14C]-OTL0038 after a single intravenous dose to healthy volunteers.
- Conditions
- imaging agent for overian cancerovarian cancer
- Registration Number
- NL-OMON48212
- Lead Sponsor
- On Target Laboratories, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
1. Able to provide informed consent to participate in this study after reading
the participant information sheet and informed consent form and after having
the opportunity to discuss the study with the Investigator or designee.
2. Healthy and free from clinically significant illness or disease as
determined by medical history, physical examination, laboratory and other tests
at Screening.
3. Male Caucasian subjects, aged 18 to 60 years (inclusive) at Screening.
1. Any finding of the medical examination (including blood pressure, pulse rate
and ECG) deviating from normal and of clinical relevance.
2. History or current clinically significant gastrointestinal, hepatic, renal,
respiratory, cardiovascular, metabolic, immunologic, hormonal disorders.
3. History of any major surgery within the last 4 weeks before Screening or any
bone fracture within the last 2 months before Screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method