Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers
Study Details
Study Description
Brief Summary
Open-label Phase I pharmacokinetic (PK) study of Vasostrict® (vasopressin injection, USP) in healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Plasma Clearance of vasopressin following IV administration in participants with TT genotype versus AA/AT genotype [15 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endo Clinical Trial Site #2 | Orlando | Florida | United States | 32806 |
| 2 | Endo Clinical Trial Site #1 | Austin | Texas | United States | 78744 |
Sponsors and Collaborators
- Endo Pharmaceuticals
Investigators
- Study Director: Shannon Dalton, Endo Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PS4229-101