acromegaly extreme growth
Conditions
Interventions
Part 1: ONO-5788 will be given as an oral capsule with 240 milliliters (mL) of
water. Two hours and 15 minutes after intake of the capsule, an intravenous
infusion of 0.1 mg [14C]-ONO-5788 will star
Sponsors
Ono Pharma UK Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 Absolute BA of ONO-5788 in plasma. Part 2 Total recovery of radioactivity in urine and faeces following a single oral dose of [14C]-ONO-5788 (expressed as a percentage of the total radioactive dose administered). | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and 2 PK parameters of total drug-related material (radioactivity, ONO-5788, and ONO-ST1-641) in blood and plasma (Table 4). Blood/plasma ratio of total drug-related material (radioactivity, ONO-5788, and ONO-ST1-641). Safety and tolerability parameters including collection of adverse events (AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs), and laboratory evaluations. Part 2 Characterization and identification of [14C]-ONO-5788 metabolites in plasma, urine and faeces. PK parameters of total radioactivity in urine. | — |
Countries
Netherlands
Outcome results
None listed