Status:
COMPLETED
Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Healthy Volunteer Safety Study
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Open-label Phase I pharmacokinetic (PK) study of Vasostrict® (vasopressin injection, USP) in healthy volunteers.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04093050
Start Date
October 10 2019
End Date
April 11 2021
Last Update
May 19 2021
Active Locations (2)
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1
Endo Clinical Trial Site #2
Orlando, Florida, United States, 32806
2
Endo Clinical Trial Site #1
Austin, Texas, United States, 78744