Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteer Safety Study

In brief

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

Key facts

Study ID

NCT04093050

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

41

Starts

2019-10-10

Expected to finish

2021-04-11

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Participant is willing and able to comply with all aspects of the protocol, including the diet and medication restrictions.

You may not qualify if…

• If female, breastfeeding or pregnant.
• Use of any prescription or over-the-counter drugs.
• Clinical laboratory test results outside laboratory normal range that are determined by the investigator to be clinically significant.
• Creatinine clearance <90 mL/min (estimated by Cockcroft-Gault formula).
• 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.
• 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).
• History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
• 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.
• Known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.
• 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.
• History of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
• 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.
• 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.
• 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]).
• Participation in a clinical trial of an investigational drug within the 30 days prior to admission on Day -2.
• Significant blood loss or donation (≥500 mL within the 30 days prior to admission on Day -2).
• Is an employee or the close relative of an employee of the sponsor or clinical unit.

Where it is running

• Endo Clinical Trial Site #2 — Orlando, Florida, United States
• Endo Clinical Trial Site #1 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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