Safety and Pharmacokinetics of Vasopressin in Healthy Volunteers

NCT ID: NCT04093050

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2021-04-11

Brief Summary

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

Conditions

Healthy Volunteer Safety Study

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TT Genotype

Group Type: EXPERIMENTAL

Vasostrict Injectable Product

Intervention Type: DRUG

Vasostrict® (vasopressin injection, USP)

AA/AT Genotype

Group Type: EXPERIMENTAL

Vasostrict Injectable Product

Intervention Type: DRUG

Vasostrict® (vasopressin injection, USP)

Interventions

Vasostrict Injectable Product

Vasostrict® (vasopressin injection, USP)

Intervention Type: DRUG

Eligibility 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. 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.

6. Participant 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 participant 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shannon Dalton

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Endo Clinical Trial Site #2

Orlando, Florida, United States

Endo Clinical Trial Site #1

Austin, Texas, United States

Countries

United States

Other Identifiers

PS4229-101

Identifier Type: -

Identifier Source: org_study_id