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Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers
Plain-language guide to NCT04093050: phase 1 non-randomized trial of Vasopressin, 41 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04093050
- Phase
- phase 1
- Status
- completed
- Start
- 2019-10-10
- Completion (planned or actual)
- 2021-04-08
- Participants
- 41 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Volunteer Safety Study
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Vasopressin.
It had two arms (groups): TT Genotype (experimental) and AA/AT Genotype (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 41 actual participants took part.
It was open to people of any sex aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Signed the informed consent form (ICF) approved by an institutional review board (IRB). Determined to have genotype TT, AA, or AT. Weighs at least 50 kg and not more than 100 kg. If female, must be surgically sterile for at least 6 months prior to screening, post-menopausal for at least 1 year, using adequate contraception, have a vasectomized partner or abstinent. Participant is in good physical health as determined by the investigator, based on physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory tests.
The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: if female, breastfeeding or pregnant; use of any prescription or over-the-counter drugs; known allergy or hypersensitivity to 8-l-arginine vasopressin or chlorobutanol.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
The Vasopressin group and the comparison group ran side by side rather than switching.
Everyone knew when Vasopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2019-10-10 with completion listed for 2021-04-08.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Plasma Clearance of vasopressin following IV administration in participants with TT genotype versus AA/AT genotype (time frame: 15 days).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Vasopressin in 41 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Vasopressin compound page, all human trials.
Our Notes on the Compound
Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.