An open-label, single-dose study to evaluate the excretion and metabolism of oral [14C]-ONO-5788, and absolute bioavailability of oral ONO-5788 in healthy adult male subjects
- Conditions
- acromegalyextreme growth10021112
- Registration Number
- NL-OMON48245
- Lead Sponsor
- Ono Pharma UK Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. The subject is willing and able to provide written informed consent.
2. Male subjects aged 21 to 65 inclusive at the time of signing the informed consent form.
3. The subject is able to communicate with the Investigator and the site staff.
4. A subject is eligible to participate if he is not trying to father a child, is willing to use one of the contraception methods listed in Section 5.3 and agrees not to donate sperm, from Day 1 of the study until 90 days after dosing.
5. The subject has a body mass index of 18.5 to 30.0 kg/m2, inclusive at screening.
1. The Investigator deems the subject unsuitable for the study as a result of the screening examinations.
2. The subject is an employee of the Sponsor or contract research organization.
3. The subject has, or has a history of, any significant disease or disorder that would increase the risk for the subject if they were enrolled in the study or would affect study procedures or outcomes such as:
a. Gallstones, cholangitis, and/or cholecystitis;
b. Pancreatitis;
c. Hypothyroidism;
d. Known diabetes mellitus type 1 or type 2;
e. Hypocalcaemia or hypokalaemia;
f. Hypoglycaemia or hyperglycaemia or fasting blood glucose outside normal local range;
g. Thrombocytopenia or other clinically significant haematologic abnormalities;
h. Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery (with the exception of appendectomy);
i. Known vitamin B12 deficiency.
4. The subject has a positive, pre-study, hepatitis B, hepatitis C or human immunodeficiency virus test.
5. The subject has clinically significant serum electrolyte (sodium, potassium, chloride, bicarbonate) abnormalities at screening or admission, in the estimation and clinical judgment of the Investigator or designee.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1<br /><br>Absolute BA of ONO-5788 in plasma.<br /><br><br /><br>Part 2<br /><br>Total recovery of radioactivity in urine and faeces following a single oral<br /><br>dose of [14C]-ONO-5788 (expressed as a percentage of the total radioactive dose<br /><br>administered).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1 and 2<br /><br>PK parameters of total drug-related material (radioactivity, ONO-5788, and<br /><br>ONO-ST1-641) in blood and plasma (Table 4).<br /><br>Blood/plasma ratio of total drug-related material (radioactivity, ONO-5788, and<br /><br>ONO-ST1-641).<br /><br>Safety and tolerability parameters including collection of adverse events<br /><br>(AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs),<br /><br>and laboratory evaluations.<br /><br><br /><br>Part 2<br /><br>Characterization and identification of [14C]-ONO-5788 metabolites in plasma,<br /><br>urine and faeces.<br /><br>PK parameters of total radioactivity in urine.</p><br>