Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers

NCT04093050 | Completed Phase 1 FDA Drug

• 1 other identifier: PS4229-101
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Volunteer Safety Study

Outcome Measures

Primary Outcomes (1)

• Plasma Clearance of vasopressin following IV administration in participants with TT genotype versus AA/AT genotype

  15 days

Study Arms (2)

TT Genotype

EXPERIMENTAL

Drug: Vasostrict Injectable Product

AA/AT Genotype

EXPERIMENTAL

Drug: Vasostrict Injectable Product

Interventions

Vasostrict Injectable Product DRUG

Vasostrict® (vasopressin injection, USP)

AA/AT Genotype; TT Genotype

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (2)

Endo Clinical Trial Site #2

Orlando, Florida, 32806, United States

Location

Endo Clinical Trial Site #1

Austin, Texas, 78744, United States

Location

Study Officials

• Shannon Dalton

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 17, 2019
• Study Start: October 10, 2019
• Primary Completion: April 8, 2021
• Study Completion: April 11, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (2)