Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-03-10 @ 11:32 PM
Study NCT ID:
NCT03948451
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD5718 in Volunteers
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: