A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers

What Was Tested

This registered phase 1 trial tested Desmopressin.

Study BT200-01 is a first in human (FIH) study in male and female normal human volunteers (NHVs) that uses an Integrated Protocol Design.

The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs.

It had 18 arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

112 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Healthy male or female volunteers, age ≥ 18 years old at screening. If female, must be post-menopausal or status post hysterectomy. Able to comprehend and to give informed consent. Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities.

How the Study Was Run

The set-up was randomized, sequential and triple-blind.

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-10-07 with completion listed for 2020-09-14.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0.

It also tracked 3 secondary outcomes, for example Measured Area Under the Curve (AUC), Maximum Plasma Concentration (Cmax) and Time to Maximum Plasma Concentration (Tmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Desmopressin in 112 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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