Study S000627

A Single Part, Three-Way Crossover, Randomised, Open-Label Study Designed to Evaluate the Relative and Absolute Bioavailability Following a Single Subcutaneous Injection of a Novel High Concentration Subcutaneous Formulation of Cotadutide Against a Low Concentration Subcutaneous Formulation and Intravenous (IV) Formulation for Reference, in Healthy Subjects

ClinicalTrials.gov record

Registration

Registration: NCT05294458
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 10
Start: 2022-03-28
Primary completion: 2022-09-12
Lead sponsor: AstraZeneca
Conditions: Non-alcoholic Steatohepatitis; Type 2 Diabetes Mellitus (T2DM); Chronic Kidney Disease
Interventions: DRUG:cotadutide solution for injection
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2021-005442-15

Registered primary outcomes

Absolute bioavailability of the high and the low concentration cotadutide SC formulations [Collection of plasma samples from pre-dose to 72 hours post-dose.]
Maximum observed concentration (cmax) [Collection of plasma samples from pre-dose to 72 hours post-dose.]
Relative bioavailability of a high concentration cotadutide SC formulation in comparison to low concentration formulation, in the fasted state [Collection of plasma samples from pre-dose to 72 hours post-dose.]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.