NCT03948451

Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD5718 in Volunteers

A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5718 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease. The study is an open-label, single dose study involving 6 healthy male subjects. The volunteers will receive a single dose of 200 mg radiolabelled AZD5718 (14C-AZD5718 Oral Suspension) containing not more than 9.9 MBq of radiocarbon. Volunteers will attend the clinic for 9 days (Day -1 to Day 8) to receive a single dose of the test medicine. It is planned that the volunteers will be discharged as a group once all volunteers have reached the discharge criteria. This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the discharge criteria are not met by volunteers by Day 8, the individual volunteers who have not met the criteria will remain in the clinical unit for a further 48 h (until Day 10). A follow-up call will take place 7 to 10 days after discharge to ensure the ongoing wellbeing of volunteers.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	[14C]AZD5718 Oral Suspension	200 mg dose of \[14C\]AZD5718 Oral Suspension

Timeline

• Start date: 2019-04-30
• Primary completion: 2019-07-02
• Completion: 2019-07-02
• First posted: 2019-05-14
• Last updated: 2019-07-15

Locations

1 site across 1 country: United Kingdom