We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04093050
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : May 19, 2021
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
Open-label Phase I pharmacokinetic (PK) study of Vasostrict® (vasopressin injection, USP) in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Safety Study Drug: Vasostrict Injectable Product Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Two-Arm, Parallel-Group, Pharmacokinetic Study on Plasma Clearance of Vasopressin in Healthy Volunteers
Actual Study Start Date : October 10, 2019
Actual Primary Completion Date : April 8, 2021
Actual Study Completion Date : April 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: TT Genotype Drug: Vasostrict Injectable Product
Vasostrict® (vasopressin injection, USP)

Experimental: AA/AT Genotype Drug: Vasostrict Injectable Product
Vasostrict® (vasopressin injection, USP)

Primary Outcome Measures :
  1. Plasma Clearance of vasopressin following IV administration in participants with TT genotype versus AA/AT genotype [ Time Frame: 15 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Signed the informed consent form (ICF) approved by an institutional review board (IRB).
  2. Determined to have genotype TT, AA, or AT.
  3. Weighs at least 50 kg and not more than 100 kg.
  4. 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.
  5. 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.
  6. Participant is willing and able to comply with all aspects of the protocol, including the diet and medication restrictions.

Exclusion Criteria:

  1. If female, breastfeeding or pregnant.
  2. Use of any prescription or over-the-counter drugs.
  3. Clinical laboratory test results outside laboratory normal range that are determined by the investigator to be clinically significant.
  4. Creatinine clearance <90 mL/min (estimated by Cockcroft-Gault formula).
  5. Pulse rate ≤50 or ≥100 bpm, systolic blood pressure ≤90 or ≥140 mmHg, diastolic blood pressure ≤60 or ≥90 mmHg or a history of hypertension, recurrent hypotensive events, or known orthostatic hypotension.
  6. ECG abnormalities (PR >200 msec; QRS complex >120 msec; QT interval corrected for heart rate using Fridericia's formula [QTcF] interval >450 msec if male and >470 msec if female, or history of clinically significant ECG abnormalities (such as cardiac arrhythmia, familial long QT syndrome, or previous torsade de pointes).
  7. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
  8. History or evidence of any clinically significant surgical or medical condition (eg, cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, dermatologic, renal, and/or another major disease or malignancy) that would be anticipated, in the opinion of the investigator, to compromise participant safety or PK evaluation.
  9. Known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.
  10. Clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies), as judged by the investigator.
  11. History of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
  12. Use of tobacco- or nicotine-containing products in the 6 months prior or intent to smoke during the study. Smoking status will be confirmed by negative urine cotinine test.
  13. Consumption of more than 21 units (males) or more than 14 units (females) of alcohol per week (1 unit = 10 g pure alcohol or 250 mL of beer [5%], 35 mL of spirits [35%], or 100 mL of wine [12%]). Alcohol use is prohibited from 72 hours prior to admission on Day -2 until discharge from clinical unit.
  14. History of chronic drug or alcohol abuse in the last 4 years. Lack of abuse will be confirmed by urine screens for alcohol and drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, methamphetamines, methylenedioxymethamphetamine, and opiates [including heroin, codeine, and oxycodone]).
  15. Participation in a clinical trial of an investigational drug within the 30 days prior to admission on Day -2.
  16. Significant blood loss or donation (≥500 mL within the 30 days prior to admission on Day -2).
  17. Is an employee or the close relative of an employee of the sponsor or clinical unit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093050

Layout table for location information
United States, Florida
Endo Clinical Trial Site #2
Orlando, Florida, United States, 32806
United States, Texas
Endo Clinical Trial Site #1
Austin, Texas, United States, 78744
Sponsors and Collaborators
Endo Pharmaceuticals
Layout table for investigator information
Study Director: Shannon Dalton Endo Pharmaceuticals
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04093050    
Other Study ID Numbers: PS4229-101
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs