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Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04093050
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vasopressin

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

Placebo Comparator: 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: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. Subject 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. Subject 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 subject 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


Contacts
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Contact: Ray Perone 800-462-3636 ClinicalTrials@Endo.com

Locations
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United States, Texas
Endo Clinical Trial Site #1 Recruiting
Austin, Texas, United States, 78744
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Shannon Dalton Endo Pharmaceuticals

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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04093050     History of Changes
Other Study ID Numbers: PS4229-101
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs