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
Abstract
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral ONO-5788. The study will be conducted in two parts: Part 1 to assess the absolute bioavailability using ONO-5788 and radiolabelled ONO-5788 as intravenous and oral forms; part 2 will assess the mass balance of ONO-5788 using orally administered radiolabelled ONO-5788
Conditions: Acromegaly.
Primary outcome: Absolute bioavailability of ONO-5788 in plasma; Mass balance of ONO-5788.
Enrollment: 12 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
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