Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

What Was Tested

This registered phase 1 trial tested Sincalide.

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.

It had two arms (groups): Group 1 (experimental) and Group 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 9 actual participants took part.

It was open to men only aged from 21 years up to 65 years.

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

Examples of who could join: Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height \[m\])2. Males must agree to follow specific methods of contraception, if applicable.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment; any major surgery within 6 weeks of study treatment administration.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Sincalide group and the comparison group ran side by side rather than switching.

Being open-label, the Sincalide study did not mask who received what.

It started in 2020-10-15 with completion listed for 2021-04-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum observed plasma concentration (Cmax) of BMS-986278 (time frame: Up to 15 days). Maximum observed plasma concentration (Cmax) of total radioactivity (TRA) (time frame: Up to 15 days). Time of maximum observed plasma concentration (Tmax) of BMS-986278 (time frame: Up to 15 days).

It also tracked 12 secondary outcomes, for example Incidence of Adverse Events (AEs) and Incidence of Serious Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Sincalide in 9 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 Sincalide compound page, all human trials.