drugset
drugset / Trial / NCT03849872

Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788

NCT03849872 ↗

Phase 1 Completed 12 enrolled Ono Pharmaceutical Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2019-02-27
Primary completion
2019-04-02
Completion
2019-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject ONO-5788 Unknown 0.041 mbq Oral
Subject ONO-5788 Unknown 100 ug Oral
Subject ONO-5788 Unknown 4.1 mbq Oral
Subject ONO-5788 Unknown 10 mg Oral

Indications

acromegaly