A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide

What Was Tested

This registered phase 1 trial tested Cotadutide.

This is a randomized, open label, cross-over study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites.

The study will be conducted at a single US center.

It had six arms (groups): Sequence 1 (experimental), Sequence 2 (experimental), Sequence 3 (experimental), Sequence 4 (experimental) and Sequence 5 (experimental).

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy subjects aged 18 through 60 years (inclusive) at the time of screening. Electronic and/or written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. BMI between 19 and 30 kg/m2 (inclusive) at screening. Good general health as judged by the investigator, based on medical history, physical examination including 12 lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product, and must not be breastfeeding.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: active hepatitis b, measured by positive tests of surface antigen hbsag and/or active hepatitis c, measured by positive hepatitis c virus antibody tests; positive human immunodeficiency virus (hiv) antibodies; subjects with a history of acute or chronic pancreatitis.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Cotadutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Cotadutide and the comparison in turn, acting as their own control.

Everyone knew when Cotadutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-09-27 with completion listed for 2020-03-06.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Area under the plasma concentration time curve (time frame: 48 hours).

It also tracked 7 secondary outcomes, for example Maximum observed plasma drug concentration, Area under the plasma concentration time curve from zero to infinity, Time to maximum observed plasma drug concentration, Terminal phase elimination half life, Apparent clearance and Anti drug antibody incidence and titer.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cotadutide in 36 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cotadutide compound page, all human trials.