Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD5718 in Volunteers
Status:
Completed
Trial end date:
2019-07-02
Target enrollment:
Participant gender:
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.