imaging agent for overian cancer ovarian cancer
Conditions
Interventions
Up to 8 healthy male subjects will receive a single 60 minute i.v. infusion of
1.75 mg [14C]-OTL0038 containing approximately 105 µCi radioactivity.
Sponsors
On Target Laboratories, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radioactivity and Pharmacokinetic Parameters Total radioactivity and PK parameters will be derived by non-compartmental analysis from total radioactivity-time as well as unchanged parent drug-time profiles. Safety and Tolerability Parameters Baseline is defined as the last available and evaluable value measured prior to [14C]-OTL0038 administration (vital signs, ECG, laboratory parameters), unless otherwise specified. The following are defined as safety/tolerability parameters: Adverse events Vital signs 12-lead ECG Clinical laboratory parameters Local tolerability Weight Physical examination Calculation of Mass Balance Individual plasma and whole blood total radioactivity as well as unchanged parent drug (LC-MS/MS) data will be used to directly obtain Cmax and tmax, respectively. Mass balance will be calculated as the percent of total administered radioactivity recovered in urine and feces. To calculate mass balance, the amount of administered radioactivity is defined as the total radioactivity in the dosing solution minus any radioactivity loss due to adsorption to the infusion bag, etc. The PK parameters on total radioactivity as well as unchanged parent drug (LC-MS/MS) data in plasma and whole blood will be based on actual blood sampling times [h] (relative to the corresponding administration time) rounded to two digits and negative pre-dose times will be set to zero. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs values; Clinical laboratory values; Number of subjects with adverse events (AEs); 12-lead ECG values. Local tolerance Weight Physical examination outcomes. | — |
Countries
Netherlands
Outcome results
None listed