NCT03849872

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	ONO-5788	Investigational Drug
DRUG	[14C]-ONO-5788	Investigational Drug

Timeline

• Start date: 2019-02-27
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2019-02-21
• Last updated: 2019-11-07

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study