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

NCT03948451 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-07-15

No results posted yet for this study

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

Interventions

DRUG

[14C]AZD5718 Oral Suspension

200 mg dose of \[14C\]AZD5718 Oral Suspension

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChB, BAO, MRCS, MFPM · Quotient Sciences Limited (indemnified by Medical Protection Society)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2019-07-02
Completion
2019-07-02

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948451 on ClinicalTrials.gov